Scientists Say New Material Could Hold up an Actual Space Elevator

Space Elevator

It takes a lot of energy to put stuff in space. That’s why one longtime futurist dream is a “space elevator” — a long cable strung between a geostationary satellite and the Earth that astronauts could use like a dumbwaiter to haul stuff up into orbit.

The problem is that such a system would require an extraordinarily light, strong cable. Now, researchers from Beijing’s Tsinghua University say they’ve developed a carbon nanotube fiber so sturdy and lightweight that it could be used to build an actual space elevator.

Going Up

The researchers published their paper in May, but it’s now garnering the attention of their peers. Some believe the Tsinghua team’s material really could lead to the creation of an elevator that would make it cheaper to move astronauts and materials into space.

“This is a breakthrough,” colleague Wang Changqing, who studies space elevators at Northwestern Polytechnical University, told the South China Morning Post.

Huge If True

There are still countless galling technical problems that need to be overcome before a space elevator would start to look plausible. Wang pointed out that it’d require tens of thousands of kilometers of the new material, for instance, as well as a shield to protect it from space debris.

But the research brings us one step closer to what could be a true game changer: a vastly less expensive way to move people and spacecraft out of Earth’s gravity.

READ MORE: China Has Strongest Fibre That Can Haul 160 Elephants – and a Space Elevator? [South China Morning Post]

More on space elevators: Why Space Elevators Could Be the Future of Space Travel

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Scientists Say New Material Could Hold up an Actual Space Elevator

Report Identifies China as the Source of Ozone-Destroying Emissions

Emissions Enigma

For years, a mystery puzzled environmental scientists. The world had banned the use of many ozone-depleting compounds in 2010. So why were global emission levels still so high?

The picture started to clear up in June. That’s when The New York Times published an investigation into the issue. China, the paper claimed, was to blame for these mystery emissions. Now it turns out the paper was probably right to point a finger.

Accident or Incident

In a paper published recently in the journal Geophysical Research Letters, an international team of researchers confirms that eastern China is the source of at least half of the 40,000 tonnes of carbon tetrachloride emissions currently entering the atmosphere each year.

They figured this out using a combination of ground-based and airborne atmospheric concentration data from near the Korean peninsula. They also relied on two models that simulated how the gases would move through the atmosphere.

Though they were able to narrow down the source to China, the researchers weren’t able to say exactly who’s breaking the ban and whether they even know about the damage they’re doing.

Pinpoint

“Our work shows the location of carbon tetrachloride emissions,” said co-author Matt Rigby in a press release. “However, we don’t yet know the processes or industries that are responsible. This is important because we don’t know if it is being produced intentionally or inadvertently.”

If we can pinpoint the source of these emissions, we can start working on stopping them and healing our ozone. And given that we’ve gone nearly a decade with minimal progress on that front, there’s really no time to waste.

READ MORE: Location of Large ‘Mystery’ Source of Banned Ozone Depleting Substance Uncovered [University of Bristol]

More on carbon emissions: China Has (Probably) Been Pumping a Banned Gas Into the Atmosphere

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Report Identifies China as the Source of Ozone-Destroying Emissions

An AI Conference Refusing a Name Change Highlights a Tech Industry Problem

Name Game

There’s a prominent artificial intelligence conference that goes by the suggestive acronym NIPS, which stands for “Neural Information Processing Systems.”

After receiving complaints that the acronym was alienating to women, the conference’s leadership collected suggestions for a new name via an online poll, according to WIRED. But the conference announced Monday that it would be sticking with NIPS all the same.

Knock It Off

It’s convenient to imagine that this acronym just sort of emerged by coincidence, but let’s not indulge in that particular fantasy.

It’s more likely that tech geeks cackled maniacally when they came up with the acronym, and the refusal to do better even when people looking up the conference in good faith are bombarded with porn is a particularly telling failure of the AI research community.

Small Things Matter

This problem goes far beyond a silly name — women are severely underrepresented in technology research and even more so when it comes to artificial intelligence. And if human decency — comforting those who are regularly alienated by the powers that be — isn’t enough of a reason to challenge the sexist culture embedded in tech research, just think about what we miss out on.

True progress in artificial intelligence cannot happen without a broad range of diverse voices — voices that are silenced by “locker room talk” among an old boy’s club. Otherwise, our technological development will become just as stuck in place as our cultural development often seems to be.

READ MORE: AI RESEARCHERS FIGHT OVER FOUR LETTERS: NIPS [WIRED]

More on Silicon Valley sexism: The Tech Industry’s Gender Problem Isn’t Just Hurting Women

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An AI Conference Refusing a Name Change Highlights a Tech Industry Problem

This AI Lie Detector Flags Falsified Police Reports

Minority Report

Imagine this: You file a police report, but back at the station, they feed it into an algorithm — and it accuses you of lying, as though it had somehow looked inside your brain.

That might sound like science fiction, but Spain is currently rolling out a very similar program, called VeriPol, in many of its police stations. VeriPol’s creators say that when it flags a report as false, it turns out to be correct more than four-fifths of the time.

Lie Detector

VeriPol is the work of researchers at Cardiff University and Charles III University of Madrid.

In a paper published earlier this year in the journal Knowledge-Based Systems, they describe how they trained the lie detector with a data set of more than 1,000 robbery reports — including a number that police identified as false — to identify subtle signs that a report wasn’t true.

Thought Crime

In pilot studies in Murcia and Malaga, Quartz reported, further investigation showed that the algorithm was correct about 83 percent of the time that it suspected a report was false.

Still, the project raises uncomfortable questions about allowing algorithms to act as lie detectors. Fast Company reported earlier this year that authorities in the United States, Canada, and the European Union are testing a separate system called AVATAR that they want to use to collect biometric data about subjects at border crossings — and analyze it for signs that they’re not being truthful.

Maybe the real question isn’t whether the tech works, but whether we want to permit authorities to act upon what’s essentially a good — but not perfect — assumption that someone is lying.

READ MORE: Police Are Using Artificial Intelligence to Spot Written Lies [Quartz]

More on lie detectors: Stormy Daniels Took a Polygraph. What Do We Do With the Results?

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This AI Lie Detector Flags Falsified Police Reports

These Bacteria Digest Food Waste Into Biodegradable Plastic

Factory Farm

Plastics have revolutionized manufacturing, but they’re still terrible for the environment.

Manufacturing plastics is an energy-intensive slog that ends in mountains of toxic industrial waste and greenhouse gas emissions. And then the plastic itself that we use ends up sitting in a garbage heap for thousands of years before it biodegrades.

Scientists have spent years investigating ways to manufacture plastics without ruining the planet, and a Toronto biotech startup called Genecis says it’s found a good answer: factories where vats of bacteria digest food waste and use it to form biodegradable plastic in their tiny microbial guts.

One-Two Punch

The plastic-pooping bacteria stand to clean up several kinds of pollution while churning out usable materials, according to Genecis.

That’s because the microbes feed on waste food or other organic materials — waste that CBC reported gives off 20 percent of Canada’s methane emissions as it sits in landfills.

Then What?

The plastic that the little buggers produce isn’t anything new. It’s called PHA and it’s used in anything that needs to biodegrade quickly, like those self-dissolving stitches. What’s new here is that food waste is much cheaper than the raw materials that usually go into plastics, leading Genecis to suspect it can make the same plastics for 40 percent less cost.

There are a lot of buzzworthy new alternative materials out there, but with a clear environmental and financial benefit, it’s possible these little bacteria factories might be here to stay.

READ MORE: Greener coffee pods? Bacteria help turn food waste into compostable plastic [CBC]

More on cleaning up plastics: The EU Just Voted to Completely ban Single-Use Plastics

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These Bacteria Digest Food Waste Into Biodegradable Plastic

You Can Now Preorder a $150,000 Hoverbike

Please, Santa?

It’s never too early to start writing your Christmas wish list, right? Because we know what’s now at the top of ours: a hoverbike.

We’ve had our eyes on Hoversurf’s Scorpion-3 since early last year — but now, the Russian drone start-up is accepting preorders on an updated version of the vehicle.

Flying Bike

The S3 2019 is part motorcycle and part quadcopter. According to the Hoversurf website, the battery-powered vehicle weighs 253 pounds and has a flight time of 10 to 25 minutes depending on operator weight. Its maximum legal speed is 60 mph — though as for how fast the craft can actually move, that’s unknown. Hoversurf also notes that the vehicle’s “safe flight altitude” is 16 feet, but again, we aren’t sure how high it can actually soar.

What we do know: The four blades that provide S3 with its lift spin at shin level, and while this certainly looks like it would be a safety hazard, the U.S. Department of Transportation’s Federal Aviation Administration approved the craft for legal use as an ultralight vehicle in September.

That means you can only operate an S3 for recreational or sports purposes — but you can’t cruise to work on your morning commute.

Plummeting Bank Account

You don’t need a pilot’s license to operate an S3, but you will need a decent amount of disposable income — the Star Wars-esque craft will set you back $150,000.

If that number doesn’t cause your eyes to cross, go ahead and slap down the $10,000 deposit needed to claim a spot in the reservation queue. You’ll then receive an email when it’s time to to place your order. You can expect to receive your S3 2019 two to six months after that, according to the company website.

That means there’s a pretty good chance you won’t be able to hover around your front yard this Christmas morning, but a 2019 jaunt is a genuine possibility.

READ MORE: For $150,000 You Can Now Order Your Own Hoverbike [New Atlas]

More on Hoversurf: Watch the World’s First Rideable Hoverbike in Flight

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You Can Now Preorder a $150,000 Hoverbike

FBI’s Tesla Criminal Probe Reportedly Centers on Model 3 Production

Ups and Downs

Can we please get off Mr. Musk’s Wild Ride now? We don’t know how much more of this Tesla rollercoaster we can take.

In 2018 alone, Elon Musk’s clean energy company has endured a faulty flufferbot, furious investors, and an SEC probe and settlement. But there was good news, too. Model 3 deliveries reportedly increased, and just this week, we found out that Tesla had a historic financial quarter, generating $312 million in profit.

And now we’re plummeting again.

Closing In

On Friday, The Wall Street Journal reported that the Federal Bureau of Investigation (FBI) is deepening a criminal probe into whether Tesla “misstated information about production of its Model 3 sedans and misled investors about the company’s business going back to early 2017.”

We’ve known about the FBI’s Tesla criminal probe since September 18, but this is the first report confirming that Model 3 production is at the center of the investigation.

According to the WSJ’s sources, FBI agents have been reaching out to former Tesla employees in recent weeks to ask if they’d be willing to testify in the criminal case, though no word yet on whether any have agreed.

Casual CEO

We might be having trouble keeping up with these twists and turns, but Musk seems to be taking the FBI’s Tesla criminal probe all in stride — he spent much of Friday afternoon joking around with his Twitter followers about dank memes.

Clearly he has the stomach for this, but it’d be hard to blame any Tesla investors for deciding they’d had enough.

READ MORE: Tesla Faces Deepening Criminal Probe Over Whether It Misstated Production Figures [The Wall Street Journal]

More on Tesla: Elon Musk Says Your Tesla Will Earn You Money While You Sleep

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FBI’s Tesla Criminal Probe Reportedly Centers on Model 3 Production

Zero Gravity Causes Worrisome Changes In Astronauts’ Brains

Danger, Will Robinson

As famous Canadian astronaut Chris Hadfield demonstrated with his extraterrestrial sob session, fluids behave strangely in space.

And while microgravity makes for a great viral video, it also has terrifying medical implications that we absolutely need to sort out before we send people into space for the months or years necessary for deep space exploration.

Specifically, research published Thursday In the New England Journal of Medicine demonstrated that our brains undergo lasting changes after we spend enough time in space. According to the study, cerebrospinal fluid — which normally cushions our brain and spinal cord — behaves differently in zero gravity, causing it to pool around and squish our brains.

Mysterious Symptoms

The brains of the Russian cosmonauts who were studied in the experiment mostly bounced back upon returning to Earth.

But even seven months later, some abnormalities remained. According to National Geographic, the researchers suspect that high pressure  inside the cosmonauts’ skulls may have squeezed extra water into brain cells which later drained out en masse.

Now What?

So far, scientists don’t know whether or not this brain shrinkage is related to any sort of cognitive or other neurological symptoms — it might just be a weird quirk of microgravity.

But along with other space hazards like deadly radiation and squished eyeballs, it’s clear that we have a plethora of medical questions to answer before we set out to explore the stars.

READ MORE: Cosmonaut brains show space travel causes lasting changes [National Geographic]

More on space medicine: Traveling to Mars Will Blast Astronauts With Deadly Cosmic Radiation, new Data Shows

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Zero Gravity Causes Worrisome Changes In Astronauts’ Brains

We Aren’t Growing Enough Healthy Foods to Feed Everyone on Earth

Check Yourself

The agriculture industry needs to get its priorities straight.

According to a newly published study, the world food system is producing too many unhealthy foods and not enough healthy ones.

“We simply can’t all adopt a healthy diet under the current global agriculture system,” said study co-author Evan Fraser in a press release. “Results show that the global system currently overproduces grains, fats, and sugars, while production of fruits and vegetables and, to a smaller degree, protein is not sufficient to meet the nutritional needs of the current population.”

Serving Downsized

For their study, published Tuesday in the journal PLOS ONE, researchers from the University of Guelph compared global agricultural production with consumption recommendations from Harvard University’s Healthy Eating Plate guide. Their findings were stark: The agriculture industry’s overall output of healthy foods does not match humanity’s needs.

Instead of the recommended eight servings of grains per person, it produces 12. And while nutritionists recommend we each consume 15 servings of fruits and vegetables daily, the industry produces just five. The mismatch continues for oils and fats (three servings instead of one), protein (three servings instead of five), and sugar (four servings when we don’t need any).

Overly Full Plate

The researchers don’t just point out the problem, though — they also calculated what it would take to address the lack of healthy foods while also helping the environment.

“For a growing population, our calculations suggest that the only way to eat a nutritionally balanced diet, save land, and reduce greenhouse gas emission is to consume and produce more fruits and vegetables as well as transition to diets higher in plant-based protein,” said Fraser.

A number of companies dedicated to making plant-based proteins mainstream are already gaining traction. But unfortunately, it’s unlikely that the agriculture industry will decide to prioritize growing fruits and veggies over less healthy options as long as people prefer having the latter on their plates.

READ MORE: Not Enough Fruits, Vegetables Grown to Feed the Planet, U of G Study Reveals [University of Guelph]

More on food scarcity: To Feed a Hungry Planet, We’re All Going to Need to Eat Less Meat

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We Aren’t Growing Enough Healthy Foods to Feed Everyone on Earth

Scientists May Have Put Microbes in a State of Quantum Entanglement

Hall of Mirrors

A few years ago, the journal Small published a study showing how photosynthetic bacteria could absorb and release photons as the light bounced across a minuscule gap between two mirrors.

Now, a retroactive look at the study’s data published in The Journal of Physics Communications suggests something more may have been going on. The bacteria may have been the first living organisms to operate in the realm of quantum physics, becoming entangled with the bouncing light at the quantum scale.

Cat’s Cradle

The experiment in question, as described by Scientific American, involved individual photons — the smallest quantifiable unit of light that can behave like a tiny particle but also a wave of energy within quantum physics — bouncing between two mirrors separated by a microscopic distance.

But a look at the energy levels in the experimental setup suggests that the bacteria may have become entangled, as some individual photons seem to have simultaneously interacted with and missed the bacterium at the same time.

Super Position

There’s reason to be skeptical of these results until someone actually recreates the experiment while looking for signs of quantum interactions. As with any look back at an existing study, scientists are restricted to the amount and quality of data that was already published. And, as Scientific American noted, the energy levels of the bacteria and the mirror setup should have been recorded individually — which they were not — in order to verify quantum entanglement.

But if this research holds up, it would be the first time a life form operated on the realm of quantum physics, something usually limited to subatomic particles. And even though the microbes are small, that’s a big deal.

READ MORE“Schrödinger’s Bacterium” Could Be a Quantum Biology Milestone [Scientific American]

More on quantum physics: The World’s First Practical Quantum Computer May Be Just Five Years Away

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Scientists May Have Put Microbes in a State of Quantum Entanglement

There’s No Way China’s Artificial Moon Will Work, Says Expert

Good Luck

On October 10, a Chinese organization called the Tian Fu New Area Science Society revealed plans to replace the streetlights in the city of Chengdu with a satellite designed to reflect sunlight toward the Earth’s surface at night.

But in a new interview with Astronomy, an associate professor of aerospace engineering at the University of Texas at Austin named Ryan Russel argued that based on what he’s read, the artificial moon plan would be impossible to implement.

Promised the Moon

Wu Chunfeng, the head of the Tian Fu New Area Science Society, told China Daily the artificial moon would orbit about 310 miles above Earth, delivering an expected brightness humans would perceive to be about one-fifth that of a typical streetlight.

The plan is to launch one artificial moon in 2020 and then three more in 2022 if the first works as hoped. Together, these satellites could illuminate an area of up to 4,000 square miles, Chunfeng claims.

But Russell is far from convinced.

“Their claim for 1 [low-earth orbit satellite] at [300 miles] must be a typo or misinformed spokesperson,” he told Astronomy. “The article I read implied you could hover a satellite over a particular city, which of course is not possible.”

Overkill Overhead

To keep the satellite in place over Chengdu, it would need to be about 22,000 miles above the Earth’s surface, said Russel, and its reflective surface would need to be massive to reflect sunlight from that distance. At an altitude of just 300 miles, the satellite would quickly zip around the Earth, constantly illuminating new locations.

Even if the city could put the artificial moon plan into action, though, Russell isn’t convinced it should.

“It’s a very complicated solution that affects everyone to a simple problem that affects a few,” he told Astronomy. “It’s light pollution on steroids.”

Maybe Chengdu shouldn’t give up on its streetlights just yet.

READ MORE: Why China’s Artificial Moon Probably Won’t Work [Astronomy]

More on the artificial moon: A Chinese City Plans to Replace Its Streetlights With an Artificial Moon

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There’s No Way China’s Artificial Moon Will Work, Says Expert

Clean Coal Startup Turns Human Waste Into Earth-Friendly Fuel

Gold Nuggets

A company called Ingelia says it’s figured out a way to turn human waste — the solid kind — into a combustible material it’s calling biochar. And if Ingelia’s claims are accurate, biochar can be burned for fuel just like coalexcept with nearzero greenhouse gas emissions, according to Business Insider.

That’s because almost all of the pollutants and more harmful chemicals that would normally be given off while burning solid fuels is siphoned away into treatable liquid waste, leaving a dry, combustible rod of poop fuel.

“Clean Coal

Ingelia, which is currently working to strike a deal with Spanish waste management facilities, hopes to make enough biochar to replace 220 thousand tons of coal per year, corresponding to 500 thousand tons of carbon dioxide emissions.

But that’s by 2022, at which point we’ll have even less time to reach the urgent clean energy goals of that doomsday United Nations report. In an ideal world, we would have moved away from coal years ago. At least this gives us a viable alternative as we transition to other, renewable forms of electricity.

So while we can, in part, poop our way to a better world, biochar — and other new sewage-based energy sources — will only be one of many new world-saving sources of clean energy.

READ MORE: This Spanish company found a way to produce a fuel that emits no CO2 — and it’s made of sewage [Business Insider]

More on poop: Edible Tech is Finally Useful, is Here to Help you Poop

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Clean Coal Startup Turns Human Waste Into Earth-Friendly Fuel

Ford’s Self-Driving Cars Are About to Chauffeur Your Senator

Green-Light District

It doesn’t matter how advanced our self-driving cars get — if they aren’t allowed on roads, they aren’t going to save any lives.

The future of autonomous vehicles (AVs) in the U.S. depends on how lawmakers in Washington D.C. choose to regulate the vehicles. But until now, AV testing has largely taken place far from the nation’s capital, mostly in California and Arizona.

Ford is about to change that. The company just announced plans to be the first automaker to test its self-driving cars in the Distinct of Columbia — and how lawmakers feel about those vehicles could influence future AV legislation.

Career Day

Sherif Marakby, CEO of Ford Autonomous Vehicles, announced the decision to begin testing in D.C. via a blog post last week. According to Marakby, Ford’s politician-friendly focus will be on figuring out how its AVs could promote job creation in the District.

To that end, Ford plans to assess how AVs could increase mobility in D.C., thereby helping residents get to jobs that might otherwise be outside their reach, as well as train residents for future positions as AV technicians or operators.

Up Close and Personal

Marakby notes that D.C. is a particularly suitable location for this testing because the District is usually bustling with activity. The population increases significantly during the day as commuters arrive from the suburbs for work, while millions of people flock to D.C. each year for conferences or tourism.

D.C. is also home to the people responsible for crafting and passing AV legislation. “[I]t’s important that lawmakers see self-driving vehicles with their own eyes as we keep pushing for legislation that governs their safe use across the country,” Marakby wrote.

Ford’s ultimate goal is to launch a commercial AV service in D.C. in 2021. With this testing, the company has the opportunity to directly influence the people who could help it reach that goal — or oppose it.

READ MORE: A Monumental Moment: Our Self-Driving Business Development Expands to Washington, D.C. [Medium]

More on AV legislation: U.S. Senators Reveal the Six Principles They’ll Use to Regulate Self-Driving Vehicles

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Ford’s Self-Driving Cars Are About to Chauffeur Your Senator

WHO Director: Air Pollution Is the “New Tobacco”

Wrong Direction

Breathing polluted air is as likely to kill you as tobacco use — worldwide, each kills about 7 million people annually. But while the world is making progress in the war against tobacco, air pollution is getting worse.

The Director General of the World Health Organization (WHO) hopes to change that.

“The world has turned the corner on tobacco,” wrote Tedros Adhanom Ghebreyesus in an opinion piece published by The Guardian on Saturday. “Now it must do the same for the ‘new tobacco’ — the toxic air that billions breathe every day.”

Taking Action

According to the WHO, nine out of 10 people in the world breathe polluted air.

This week, the organization is hosting the first Global Conference on Air Pollution and Health, and Ghebreyesus is hopeful world leaders will use the conference as the opportunity to commit to cutting air pollution in their nations.

“Despite the overwhelming evidence, political action is still urgently needed to boost investments and speed up action to reduce air pollution,” he wrote, noting that this action could take the form of more stringent air quality standards, improved access to clean energy, or increased investment in green technologies.

Reduced Risk

The impact sustained action against air pollution could have on public health is hard to overstate.

“No one, rich or poor, can escape air pollution. A clean and healthy environment is the single most important precondition for ensuring good health,” wrote Ghebreyesus in his Guardian piece. “By cleaning up the air we breathe, we can prevent or at least reduce some of the greatest health risks.”

The conference ends on Thursday, so we won’t have to wait long to see which nations do — or don’t — heed the WHO’s call to action.

READ MORE: Air Pollution Is the New Tobacco. Time to Tackle This Epidemic [The Guardian]

More on air pollution: Dumber Humans — That’s Just One Effect of a More Polluted Future

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WHO Director: Air Pollution Is the “New Tobacco”

Sustainable Table | Genetic Engineering

Genetically engineered (GE) or genetically modified (GM) foods are produced from plants and animals that have had changes made to their DNA, which introduce or modify genetic traits.

Most packaged foods contain genetically modified organisms (GMOs) engineered to be resistant to herbicides and pests; corn, soybeans and canola oil are prime examples. Concerns about GMOs range from their safety to how genetically modified plants pollen effects the environment, to the increasing use of herbicides associated with their use, with decreasing effectiveness. Polls show that consumers want mandatory labels on foods containing GE ingredients.

All living organisms are made up of cells, within which are strings of DNA molecules possessing instructions to make genes, which form a unique blueprint determining how an organism grows, develops, looks and lives. Genes make up about one percent of the DNA sequence; the rest is responsible for regulating when and how quantities of proteins are made.

Genetic engineering (GE) is the direct manipulation of genetic material (or the genome) by artificial means to alter the hereditary traits of a cell or organism. The process can involve the transfer of specific traits, or genes, from one organism to another, including across diverse species. Other types of genetic engineering include removing or switching off certain genes, adding new genes or introducing desired mutations. An organism that is created or modified by genetic engineering is called a genetically modified organism.

Genetic engineering is different from traditional cross-breeding methods, which have been used for millennia. Traditional breeding more closely resembles accelerated evolution: breeders select organisms with a desired trait and then further select and breed whichever of its offspring most exhibits that trait. A breeder seeking a disease-resistant tomato, for example, will grow many tomatoes, but save the seeds of only the most disease-resistant plants. After several generations, offspring will be much more disease resistant than the progenitor. Traditional breeding is done between the same or closely related species and keeps strands of DNA and gene sequences intact which can also mean that negative traits are reproduced alongside positive traits. Through genetic engineering, on the other hand, it is possible to isolate a single gene out of the whole genome and insert it into another organism.

The future of genetic engineering appears to be even more targeted than that: CRISPR technology (which stands for Clustered Regularly Interspaced Short Palindromic Repeat) allows scientists to isolate and essentially cut and paste very specific sections of DNA. This makes the process much more precise and efficient and inexpensive, making it easier for many more scientists to experiment with the technology. As it becomes more common, many scientists also urge caution, as unintended consequences, whether at the cellular, human or ecosystem level, cannot be known in advance.

Genetically engineered crops have been adopted at an exceptionally rapid rate. In 1997, 17 percent of US soybean acres were planted with GE varieties; by 2014, that figure rose to 94 percent. GE cotton usage went from 10 percent in 1997 to 91 percent in 2014. GE corn acreage increased from 25 percent in 2000 to 92 in 2017.

The vast majority of these crops have been engineered to tolerate herbicides, allowing the plants to be sprayed with a particular chemical while the surrounding weeds die. Glyphosate, the active ingredient in Roundup, is the most common. Other crops are engineered to produce their own natural pesticide (primarily to produce Bacillus thuringiensis, or Bt, a naturally-occurring bacterium that is lethal to a number of agricultural pests), to increase drought resistance or improve nutritional content. The AquAdvantage Salmon, the first GE animal approved for human consumption, was engineered for faster growth, so that it reaches market weight more quickly than a natural salmon.

In addition to corn, soybeans and cotton, the other GE crops that are commercially available in the US are potatoes, papaya, squash, canola, alfalfa, apples and sugar beets. Several others are USDA approved but are not currently produced, including tomatoes, (non-sugar) beets, rice, roses, flax, plums and tobacco. The controversial hormone rBGH (recombinant bovine growth hormone), which increases milk production in dairy cows, is genetically engineered as well.

The FLAVR SAVR tomato, engineered to retain real tomato taste after shipping, was the first GE food approved for human consumption by the US Department of Agriculture (USDA), in 1992, but has since been taken off the market. Most recently, the Impossible Burger a meatless burger that uses a genetically engineered yeast to make its signature ingredient known as heme (which accounts for its meat-like flavor) has been popping up on menus and causing controversy because it does not have FDA approval.

In the US, regulatory approvals for GMOs are a complicated patchwork of the Food and Drug Administration for pharmaceutical developments, the Environmental Protection Agency for insecticide uses and the USDA for food crops.

For many farmers, GE crops require much less work and provide a larger yield, which offsets the substantially higher cost of GE seed. One 2014 metastudy found that globally, GE crops have reduced pesticide use by 37 percent, increased crop yields by 22 percent and increased farmer profits by 68 percent. It is important to note that it was insect-resistant Bt crops that had much more advantage than herbicide-tolerant crops (from Roundup Ready seeds).

A 2014 analysis of USDA data had similar findings for insect-resistant crops in the US, but many more mixed results on herbicide resistance. Certainly, when farmers start with GE seeds, yields and profits increase in the first few years. But some studies show that this tapers off. For reasons discussed below, GMO technology is problematic for farmers and consumers alike.

On a larger scale, corporate interest plays an enormous role in the rapid growth of the technology. In 1980, the Supreme Court ruled that scientists could patent a GE bacterium developed to break down oil spills. This ruling stating that life itself could be patented and owned gave companies an incentive to develop GMOs that could be useful and profitable.

Monsanto (now part of Bayer ), the largest manufacturer of GMOs, has a long history as a chemical maker, including as one of several makers of Agent Orange, the highly toxic defoliant used during the Vietnam War. Following the war, the company turned to making agricultural chemicals, including its bestseller glyphosate herbicide, Roundup, and experimenting with genetically modifying seeds to resist the chemical so that pesticides could be liberally applied without fear of killing the crops. It introduced Roundup Ready seed in 1996 and spun off its chemical operations two years later to focus on biotechnology.

In 2017, Monsantos net sales of GE corn, soybean and cotton seeds and traits totaled $9.5 billion. Most troubling, in the last two decades, is that Monsanto has bought many competitor seed companies, giving it control of a wide swath of the seed market and its accompanying genetic diversity. In 2018, Monsanto was bought by Bayer, further consolidating the production and ownership of seed stocks around the world.

The biotech industry claims that this chemical-based agricultural technology and biotechnology is necessary to feed a growing world population, increase crop yields and adapt to a changing climate. Herbicide-resistant crops do not require tilling, which leaves carbon in the ground and is better for soil structure, and proponents claim that they require less pesticide application than non-GE crops. However, this does not tell the whole story. These crops have actually driven up the use of herbicides like glyphosate, thereby increasing weed resistance and leading to the reintroduction of more potent herbicides. These false narratives are perpetuated by biotech and other agribusiness corporations, but also by land grant universities (which receive more funding from agrochemical companies than public dollars ), many agricultural scientists and farm organizations.

However, technology and the industrialized food system are not currently feeding the world, so there is reason for skepticism about this claim. Globally, agriculture produces more than one and a half times the number of calories needed to feed the world population, yet one in nine people goes hungry. The profit motive of Bayer/Monsanto and other agrochemical companies, as well as their long lack of support for small farmers, should subject their claims of working solely for the public good to scrutiny.

When it comes to increasing calorie production for the parts of the world that sorely need to feed a hungry populace, the International Assessment of Agricultural Knowledge, Science and Technology for Development report from the United Nations proposes that organic and sustainable agriculture is the best solution for countries like Africa and India, where the need is greatest.

Much of the debate around genetically modified food crops and animals focuses on potential threats to human health. But, long-term studies of the impact of consuming GM foods have yet to be done. Some independent studies have documented health effects on animals from eating GMO foods, which have become the subject of controversy.

Companies have determined that GE crops are different enough from those derived by conventional crops to get a patent, but not different enough to require adequate safety testing before they get to market. Additional independent studies and testing are needed. Ways in which GE foods can cause health problems are already documented, particularly in terms of allergens: genes from an allergenic plant can transfer the allergen to the new plant, causing it to provoke a reaction in those sensitive to the first plant. It is also possible that new allergens could be created from combinations of genes that did not previously exist. Overall, though, we do not understand all of the potential health concerns, but that uncertainty is enough to warrant more oversight, not less.

Perhaps the most concerning consequence of herbicide-resistant crops is the huge increase in herbicide use and the evolution of herbicide-resistant superweeds. Weeds resistant to glyphosate, which have survived annual use of the herbicide, have become a problem. A 2016 survey across the Midwest found that one third to upwards of three quarters of fields showed resistant weeds. To address the problem, seed and chemical companies have turned to older chemicals such as 2,4D and dicamba, engineering seeds resistant to these more toxic compounds and increasing their use in farmers fields.

Contrary to industry promises that GE crops would require less pesticide application, chemical use has increased steadily, particularly by farmers growing herbicide-resistant crops. Farmers growing Bt pest-resistant crops have been able to decrease their insecticide use, but scientists are concerned that the effect may not last, as pests also evolve resistance.

One of the major ways that GMOs have impacted the environment, therefore, has been in a mass of side effects stemming from increased pesticide use, including compromised water quality, loss of biodiversity and threats to human health.

While biotech seeds are touted as the only way to feed a growing world population, the data on yields are mixed. It should also be noted that GE crops rely on the promise of reduced pest and weed pressure to boost yields; no successful GE technique has yet increased intrinsic yields (such as more kernels per corncob).

A 2008 literature review by the Union of Concerned Scientists found that herbicide-tolerant GE crops produced no yield gain, while Bt crops produced marginal increases. A 2013 New Zealand study found that average US GE corn yields were slightly lower than non-GE corn yields in western Europe in the same period. 2016 studies by both the National Academies of Sciences and the New York Times found no evidence that yield increases could be tied to GM technology.

Meanwhile, traditional plant breeding techniques have increased yields significantly and have even outperformed GE technology in improving drought tolerance and other factors necessary for farming in a warming climate. But investment in GE research means less funding going to these more promising methods.

Farmers adopt GE seeds and their attendant herbicides ostensibly to make farming easier and more profitable. However, GE seeds cost a lot more than conventional seeds (up to $150 more per bag, according to one report) plus the cost of herbicides. An analysis by AgriWize farm business consultant Aaron Bloom found that GM corn costs an average of $81 more per acre per season than conventional. For many farmers, the yield increase at harvest time makes the upfront costs worth it, but for others, the proliferation of superweeds or simply one bad harvest can put them in debt, with few options for how to get off the GE treadmill.

Congress passed the Plant Patenting Act in 1930, as the rise of hybrid seeds made the business of selling seeds (which since time immemorial have been freely reproducible) profitable for the first time. The law applied to certain plants only, but in 1985, it was expanded to include not only all crops but also their cells, genes and DNA. Seed patents, along with laws on intellectual property, seed marketing and more, have exploded in years since.

Humans have been breeding seeds for aeons, making plants more productive, tastier and better adapted to local conditions. In fact, adaptation has been bred into seeds throughout the ages by subsistence farmers; we take ancient farmer breeding ingenuity for granted. Todays seed patents, meanwhile, bestow rights and profits on multinational companies for discovering the newest traits, ignoring the long and unsung contributions of farmers localized agricultural knowledge.

Patents and other legal measures put control of this long heritage of seed development, and therefore our future food security, in the hands of a very few companies. The seed industry is one of the most concentrated in the US economy. Almost 80 percent of corn and more than 90 percent of soybeans grown in the US feature Monsanto/Bayer seed traits, while the top three seed firms control more than half of the total seed market, with Monsanto/Bayer alone controlling one quarter. Up-to-date numbers on seed market control are difficult to come by, however, because huge mergers in the industry, including the 2017 Dow/Dupont and the 2018 Monsanto/Bayer mergers have shifted the landscape.

These companies value their patents and other intellectual property highly. Monsanto/Bayer has filed suit against 147 farmers for violating the terms of their planting agreement and has also at times threatened or intimidated farmers.

Surveys consistently show that upwards of 90 percent of Americans support labeling of GMO foods, but unlike most developed countries including 28 nations in the European Union, Japan, Australia, Brazil, Russia and China the US had for many years no federal requirement for labels. States responded by taking the matter into their own hands. More than 70 labeling bills or ballot initiatives were introduced across 30 states, and labeling laws were passed in Vermont, Connecticut and Maine. In high-profile cases in Washington State and California, bills were defeated due to aggressive lobbying efforts by big food and biotechnology companies to the tune of $63.6 million in 2014.

In 2016, a federal law was passed, mandating labeling of GE ingredients in foods, which strikes down or pre-empts state labeling laws. The federal laws many critics dubbed it the Denying Americans the Right to Know (DARK) Act, because not only does it override state efforts (which in some cases, as in Vermont, are stringent), but because many GMOs would be exempted from being labeled. Further, the federal law states that labeling can be in the form of a digital QR code or toll-free phone number rather than a textual label that clearly marks the product as containing GMOs.

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Sustainable Table | Genetic Engineering

Genetic engineering – Wikipedia

Genetic engineering, also called genetic modification or genetic manipulation, is the direct manipulation of an organism’s genes using biotechnology. It is a set of technologies used to change the genetic makeup of cells, including the transfer of genes within and across species boundaries to produce improved or novel organisms. New DNA is obtained by either isolating and copying the genetic material of interest using recombinant DNA methods or by artificially synthesising the DNA. A construct is usually created and used to insert this DNA into the host organism. The first recombinant DNA molecule was made by Paul Berg in 1972 by combining DNA from the monkey virus SV40 with the lambda virus. As well as inserting genes, the process can be used to remove, or “knock out”, genes. The new DNA can be inserted randomly, or targeted to a specific part of the genome.

An organism that is generated through genetic engineering is considered to be genetically modified (GM) and the resulting entity is a genetically modified organism (GMO). The first GMO was a bacterium generated by Herbert Boyer and Stanley Cohen in 1973. Rudolf Jaenisch created the first GM animal when he inserted foreign DNA into a mouse in 1974. The first company to focus on genetic engineering, Genentech, was founded in 1976 and started the production of human proteins. Genetically engineered human insulin was produced in 1978 and insulin-producing bacteria were commercialised in 1982. Genetically modified food has been sold since 1994, with the release of the Flavr Savr tomato. The Flavr Savr was engineered to have a longer shelf life, but most current GM crops are modified to increase resistance to insects and herbicides. GloFish, the first GMO designed as a pet, was sold in the United States in December 2003. In 2016 salmon modified with a growth hormone were sold.

Genetic engineering has been applied in numerous fields including research, medicine, industrial biotechnology and agriculture. In research GMOs are used to study gene function and expression through loss of function, gain of function, tracking and expression experiments. By knocking out genes responsible for certain conditions it is possible to create animal model organisms of human diseases. As well as producing hormones, vaccines and other drugs genetic engineering has the potential to cure genetic diseases through gene therapy. The same techniques that are used to produce drugs can also have industrial applications such as producing enzymes for laundry detergent, cheeses and other products.

The rise of commercialised genetically modified crops has provided economic benefit to farmers in many different countries, but has also been the source of most of the controversy surrounding the technology. This has been present since its early use, the first field trials were destroyed by anti-GM activists. Although there is a scientific consensus that currently available food derived from GM crops poses no greater risk to human health than conventional food, GM food safety is a leading concern with critics. Gene flow, impact on non-target organisms, control of the food supply and intellectual property rights have also been raised as potential issues. These concerns have led to the development of a regulatory framework, which started in 1975. It has led to an international treaty, the Cartagena Protocol on Biosafety, that was adopted in 2000. Individual countries have developed their own regulatory systems regarding GMOs, with the most marked differences occurring between the USA and Europe.

Genetic engineering is a process that alters the genetic structure of an organism by either removing or introducing DNA. Unlike traditionally animal and plant breeding, which involves doing multiple crosses and then selecting for the organism with the desired phenotype, genetic engineering takes the gene directly from one organism and inserts it in the other. This is much faster, can be used to insert any genes from any organism (even ones from different domains) and prevents other undesirable genes from also being added.[3]

Genetic engineering could potentially fix severe genetic disorders in humans by replacing the defective gene with a functioning one.[4] It is an important tool in research that allows the function of specific genes to be studied.[5] Drugs, vaccines and other products have been harvested from organisms engineered to produce them.[6] Crops have been developed that aid food security by increasing yield, nutritional value and tolerance to environmental stresses.[7]

The DNA can be introduced directly into the host organism or into a cell that is then fused or hybridised with the host.[8] This relies on recombinant nucleic acid techniques to form new combinations of heritable genetic material followed by the incorporation of that material either indirectly through a vector system or directly through micro-injection, macro-injection or micro-encapsulation.[9]

Genetic engineering does not normally include traditional breeding, in vitro fertilisation, induction of polyploidy, mutagenesis and cell fusion techniques that do not use recombinant nucleic acids or a genetically modified organism in the process.[8] However, some broad definitions of genetic engineering include selective breeding.[9] Cloning and stem cell research, although not considered genetic engineering,[10] are closely related and genetic engineering can be used within them.[11] Synthetic biology is an emerging discipline that takes genetic engineering a step further by introducing artificially synthesised material into an organism.[12]

Plants, animals or micro organisms that have been changed through genetic engineering are termed genetically modified organisms or GMOs.[13] If genetic material from another species is added to the host, the resulting organism is called transgenic. If genetic material from the same species or a species that can naturally breed with the host is used the resulting organism is called cisgenic.[14] If genetic engineering is used to remove genetic material from the target organism the resulting organism is termed a knockout organism.[15] In Europe genetic modification is synonymous with genetic engineering while within the United States of America and Canada genetic modification can also be used to refer to more conventional breeding methods.[16][17][18]

Humans have altered the genomes of species for thousands of years through selective breeding, or artificial selection[19]:1[20]:1 as contrasted with natural selection, and more recently through mutagenesis. Genetic engineering as the direct manipulation of DNA by humans outside breeding and mutations has only existed since the 1970s. The term “genetic engineering” was first coined by Jack Williamson in his science fiction novel Dragon’s Island, published in 1951[21] one year before DNA’s role in heredity was confirmed by Alfred Hershey and Martha Chase,[22] and two years before James Watson and Francis Crick showed that the DNA molecule has a double-helix structure though the general concept of direct genetic manipulation was explored in rudimentary form in Stanley G. Weinbaum’s 1936 science fiction story Proteus Island.[23][24]

In 1972, Paul Berg created the first recombinant DNA molecules by combining DNA from the monkey virus SV40 with that of the lambda virus.[25] In 1973 Herbert Boyer and Stanley Cohen created the first transgenic organism by inserting antibiotic resistance genes into the plasmid of an Escherichia coli bacterium.[26][27] A year later Rudolf Jaenisch created a transgenic mouse by introducing foreign DNA into its embryo, making it the worlds first transgenic animal.[28] These achievements led to concerns in the scientific community about potential risks from genetic engineering, which were first discussed in depth at the Asilomar Conference in 1975. One of the main recommendations from this meeting was that government oversight of recombinant DNA research should be established until the technology was deemed safe.[29][30]

In 1976 Genentech, the first genetic engineering company, was founded by Herbert Boyer and Robert Swanson and a year later the company produced a human protein (somatostatin) in E.coli. Genentech announced the production of genetically engineered human insulin in 1978.[31] In 1980, the U.S. Supreme Court in the Diamond v. Chakrabarty case ruled that genetically altered life could be patented.[32] The insulin produced by bacteria was approved for release by the Food and Drug Administration (FDA) in 1982.[33]

In 1983, a biotech company, Advanced Genetic Sciences (AGS) applied for U.S. government authorisation to perform field tests with the ice-minus strain of Pseudomonas syringae to protect crops from frost, but environmental groups and protestors delayed the field tests for four years with legal challenges.[34] In 1987, the ice-minus strain of P. syringae became the first genetically modified organism (GMO) to be released into the environment[35] when a strawberry field and a potato field in California were sprayed with it.[36] Both test fields were attacked by activist groups the night before the tests occurred: “The world’s first trial site attracted the world’s first field trasher”.[35]

The first field trials of genetically engineered plants occurred in France and the USA in 1986, tobacco plants were engineered to be resistant to herbicides.[37] The Peoples Republic of China was the first country to commercialise transgenic plants, introducing a virus-resistant tobacco in 1992.[38] In 1994 Calgene attained approval to commercially release the first genetically modified food, the Flavr Savr, a tomato engineered to have a longer shelf life.[39] In 1994, the European Union approved tobacco engineered to be resistant to the herbicide bromoxynil, making it the first genetically engineered crop commercialised in Europe.[40] In 1995, Bt Potato was approved safe by the Environmental Protection Agency, after having been approved by the FDA, making it the first pesticide producing crop to be approved in the USA.[41] In 2009 11 transgenic crops were grown commercially in 25 countries, the largest of which by area grown were the USA, Brazil, Argentina, India, Canada, China, Paraguay and South Africa.[42]

In 2010, scientists at the J. Craig Venter Institute created the first synthetic genome and inserted it into an empty bacterial cell. The resulting bacterium, named Mycoplasma laboratorium, could replicate and produce proteins.[43][44] Four years later this was taken a step further when a bacterium was developed that replicated a plasmid containing a unique base pair, creating the first organism engineered to use an expanded genetic alphabet.[45][46] In 2012, Jennifer Doudna and Emmanuelle Charpentier collaborated to develop the CRISPR/Cas9 system,[47][48] a technique which can be used to easily and specifically alter the genome of almost any organism.[49]

Creating a GMO is a multi-step process. Genetic engineers must first choose what gene they wish to insert into the organism. This is driven by what the aim is for the resultant organism and is built on earlier research. Genetic screens can be carried out to determine potential genes and further tests then used to identify the best candidates. The development of microarrays, transcriptomics and genome sequencing has made it much easier to find suitable genes.[50] Luck also plays its part; the round-up ready gene was discovered after scientists noticed a bacterium thriving in the presence of the herbicide.[51]

The next step is to isolate the candidate gene. The cell containing the gene is opened and the DNA is purified.[52] The gene is separated by using restriction enzymes to cut the DNA into fragments[53] or polymerase chain reaction (PCR) to amplify up the gene segment.[54] These segments can then be extracted through gel electrophoresis. If the chosen gene or the donor organism’s genome has been well studied it may already be accessible from a genetic library. If the DNA sequence is known, but no copies of the gene are available, it can also be artificially synthesised.[55] Once isolated the gene is ligated into a plasmid that is then inserted into a bacterium. The plasmid is replicated when the bacteria divide, ensuring unlimited copies of the gene are available.[56]

Before the gene is inserted into the target organism it must be combined with other genetic elements. These include a promoter and terminator region, which initiate and end transcription. A selectable marker gene is added, which in most cases confers antibiotic resistance, so researchers can easily determine which cells have been successfully transformed. The gene can also be modified at this stage for better expression or effectiveness. These manipulations are carried out using recombinant DNA techniques, such as restriction digests, ligations and molecular cloning.[57]

There are a number of techniques available for inserting the gene into the host genome. Some bacteria can naturally take up foreign DNA. This ability can be induced in other bacteria via stress (e.g. thermal or electric shock), which increases the cell membrane’s permeability to DNA; up-taken DNA can either integrate with the genome or exist as extrachromosomal DNA. DNA is generally inserted into animal cells using microinjection, where it can be injected through the cell’s nuclear envelope directly into the nucleus, or through the use of viral vectors.[58]

In plants the DNA is often inserted using Agrobacterium-mediated recombination,[59] taking advantage of the Agrobacteriums T-DNA sequence that allows natural insertion of genetic material into plant cells.[60] Other methods include biolistics, where particles of gold or tungsten are coated with DNA and then shot into young plant cells,[61] and electroporation, which involves using an electric shock to make the cell membrane permeable to plasmid DNA. Due to the damage caused to the cells and DNA the transformation efficiency of biolistics and electroporation is lower than agrobacterial transformation and microinjection.[62]

As only a single cell is transformed with genetic material, the organism must be regenerated from that single cell. In plants this is accomplished through the use of tissue culture.[63][64] In animals it is necessary to ensure that the inserted DNA is present in the embryonic stem cells.[65] Bacteria consist of a single cell and reproduce clonally so regeneration is not necessary. Selectable markers are used to easily differentiate transformed from untransformed cells. These markers are usually present in the transgenic organism, although a number of strategies have been developed that can remove the selectable marker from the mature transgenic plant.[66]

Further testing using PCR, Southern hybridization, and DNA sequencing is conducted to confirm that an organism contains the new gene.[67] These tests can also confirm the chromosomal location and copy number of the inserted gene. The presence of the gene does not guarantee it will be expressed at appropriate levels in the target tissue so methods that look for and measure the gene products (RNA and protein) are also used. These include northern hybridisation, quantitative RT-PCR, Western blot, immunofluorescence, ELISA and phenotypic analysis.[68]

The new genetic material can be inserted randomly within the host genome or targeted to a specific location. The technique of gene targeting uses homologous recombination to make desired changes to a specific endogenous gene. This tends to occur at a relatively low frequency in plants and animals and generally requires the use of selectable markers. The frequency of gene targeting can be greatly enhanced through genome editing. Genome editing uses artificially engineered nucleases that create specific double-stranded breaks at desired locations in the genome, and use the cells endogenous mechanisms to repair the induced break by the natural processes of homologous recombination and nonhomologous end-joining. There are four families of engineered nucleases: meganucleases,[69][70] zinc finger nucleases,[71][72] transcription activator-like effector nucleases (TALENs),[73][74] and the Cas9-guideRNA system (adapted from CRISPR).[75][76] TALEN and CRISPR are the two most commonly used and each has its own advantages.[77] TALENs have greater target specificity, while CRISPR is easier to design and more efficient.[77] In addition to enhancing gene targeting, engineered nucleases can be used to introduce mutations at endogenous genes that generate a gene knockout.[78][79]

Genetic engineering has applications in medicine, research, industry and agriculture and can be used on a wide range of plants, animals and micro organisms. Bacteria, the first organisms to be genetically modified, can have plasmid DNA inserted containing new genes that code for medicines or enzymes that process food and other substrates.[80][81] Plants have been modified for insect protection, herbicide resistance, virus resistance, enhanced nutrition, tolerance to environmental pressures and the production of edible vaccines.[82] Most commercialised GMOs are insect resistant or herbicide tolerant crop plants.[83] Genetically modified animals have been used for research, model animals and the production of agricultural or pharmaceutical products. The genetically modified animals include animals with genes knocked out, increased susceptibility to disease, hormones for extra growth and the ability to express proteins in their milk.[84]

Genetic engineering has many applications to medicine that include the manufacturing of drugs, creation of model animals that mimic human conditions and gene therapy. One of the earliest uses of genetic engineering was to mass-produce human insulin in bacteria.[31] This application has now been applied to, human growth hormones, follicle stimulating hormones (for treating infertility), human albumin, monoclonal antibodies, antihemophilic factors, vaccines and many other drugs.[85][86] Mouse hybridomas, cells fused together to create monoclonal antibodies, have been adapted through genetic engineering to create human monoclonal antibodies.[87] In 2017, genetic engineering of chimeric antigen receptors on a patient’s own T-cells was approved by the U.S. FDA as a treatment for the cancer acute lymphoblastic leukemia. Genetically engineered viruses are being developed that can still confer immunity, but lack the infectious sequences.[88]

Genetic engineering is also used to create animal models of human diseases. Genetically modified mice are the most common genetically engineered animal model.[89] They have been used to study and model cancer (the oncomouse), obesity, heart disease, diabetes, arthritis, substance abuse, anxiety, aging and Parkinson disease.[90] Potential cures can be tested against these mouse models. Also genetically modified pigs have been bred with the aim of increasing the success of pig to human organ transplantation.[91]

Gene therapy is the genetic engineering of humans, generally by replacing defective genes with effective ones. Clinical research using somatic gene therapy has been conducted with several diseases, including X-linked SCID,[92] chronic lymphocytic leukemia (CLL),[93][94] and Parkinson’s disease.[95] In 2012, Alipogene tiparvovec became the first gene therapy treatment to be approved for clinical use.[96][97] In 2015 a virus was used to insert a healthy gene into the skin cells of a boy suffering from a rare skin disease, epidermolysis bullosa, in order to grow, and then graft healthy skin onto 80 percent of the boy’s body which was affected by the illness.[98] Germline gene therapy would result in any change being inheritable, which has raised concerns within the scientific community.[99][100] In 2015, CRISPR was used to edit the DNA of non-viable human embryos,[101][102] leading scientists of major world academies to call for a moratorium on inheritable human genome edits.[103] There are also concerns that the technology could be used not just for treatment, but for enhancement, modification or alteration of a human beings’ appearance, adaptability, intelligence, character or behavior.[104] The distinction between cure and enhancement can also be difficult to establish.[105]

Researchers are altering the genome of pigs to induce the growth of human organs to be used in transplants. Scientists are creating “gene drives”, changing the genomes of mosquitoes to make them immune to malaria, and then spreading the genetically altered mosquitoes throughout the mosquito population in the hopes of eliminating the disease.[106]

Genetic engineering is an important tool for natural scientists. Genes and other genetic information from a wide range of organisms can be inserted into bacteria for storage and modification, creating genetically modified bacteria in the process. Bacteria are cheap, easy to grow, clonal, multiply quickly, relatively easy to transform and can be stored at -80C almost indefinitely. Once a gene is isolated it can be stored inside the bacteria providing an unlimited supply for research.[107]

Organisms are genetically engineered to discover the functions of certain genes. This could be the effect on the phenotype of the organism, where the gene is expressed or what other genes it interacts with. These experiments generally involve loss of function, gain of function, tracking and expression.

Organisms can have their cells transformed with a gene coding for a useful protein, such as an enzyme, so that they will overexpress the desired protein. Mass quantities of the protein can then be manufactured by growing the transformed organism in bioreactor equipment using industrial fermentation, and then purifying the protein.[111] Some genes do not work well in bacteria, so yeast, insect cells or mammalians cells can also be used.[112] These techniques are used to produce medicines such as insulin, human growth hormone, and vaccines, supplements such as tryptophan, aid in the production of food (chymosin in cheese making) and fuels.[113] Other applications with genetically engineered bacteria could involve making them perform tasks outside their natural cycle, such as making biofuels,[114] cleaning up oil spills, carbon and other toxic waste[115] and detecting arsenic in drinking water.[116] Certain genetically modified microbes can also be used in biomining and bioremediation, due to their ability to extract heavy metals from their environment and incorporate them into compounds that are more easily recoverable.[117]

In materials science, a genetically modified virus has been used in a research laboratory as a scaffold for assembling a more environmentally friendly lithium-ion battery.[118][119] Bacteria have also been engineered to function as sensors by expressing a fluorescent protein under certain environmental conditions.[120]

One of the best-known and controversial applications of genetic engineering is the creation and use of genetically modified crops or genetically modified livestock to produce genetically modified food. Crops have been developed to increase production, increase tolerance to abiotic stresses, alter the composition of the food, or to produce novel products.[122]

The first crops to be realised commercially on a large scale provided protection from insect pests or tolerance to herbicides. Fungal and virus resistant crops have also been developed or are in development.[123][124] This make the insect and weed management of crops easier and can indirectly increase crop yield.[125][126] GM crops that directly improve yield by accelerating growth or making the plant more hardy (by improving salt, cold or drought tolerance) are also under development.[127] In 2016 Salmon have been genetically modified with growth hormones to reach normal adult size much faster.[128]

GMOs have been developed that modify the quality of produce by increasing the nutritional value or providing more industrially useful qualities or quantities.[127] The Amflora potato produces a more industrially useful blend of starches. Soybeans and canola have been genetically modified to produce more healthy oils.[129][130] The first commercialised GM food was a tomato that had delayed ripening, increasing its shelf life.[131]

Plants and animals have been engineered to produce materials they do not normally make. Pharming uses crops and animals as bioreactors to produce vaccines, drug intermediates, or the drugs themselves; the useful product is purified from the harvest and then used in the standard pharmaceutical production process.[132] Cows and goats have been engineered to express drugs and other proteins in their milk, and in 2009 the FDA approved a drug produced in goat milk.[133][134]

Genetic engineering has potential applications in conservation and natural area management. Gene transfer through viral vectors has been proposed as a means of controlling invasive species as well as vaccinating threatened fauna from disease.[135] Transgenic trees have been suggested as a way to confer resistance to pathogens in wild populations.[136] With the increasing risks of maladaptation in organisms as a result of climate change and other perturbations, facilitated adaptation through gene tweaking could be one solution to reducing extinction risks.[137] Applications of genetic engineering in conservation are thus far mostly theoretical and have yet to be put into practice.

Genetic engineering is also being used to create microbial art.[138] Some bacteria have been genetically engineered to create black and white photographs.[139] Novelty items such as lavender-colored carnations,[140] blue roses,[141] and glowing fish[142][143] have also been produced through genetic engineering.

The regulation of genetic engineering concerns the approaches taken by governments to assess and manage the risks associated with the development and release of GMOs. The development of a regulatory framework began in 1975, at Asilomar, California.[144] The Asilomar meeting recommended a set of voluntary guidelines regarding the use of recombinant technology.[145] As the technology improved USA established a committee at the Office of Science and Technology,[146] which assigned regulatory approval of GM food to the USDA, FDA and EPA.[147] The Cartagena Protocol on Biosafety, an international treaty that governs the transfer, handling, and use of GMOs,[148] was adopted on 29 January 2000.[149] One hundred and fifty-seven countries are members of the Protocol and many use it as a reference point for their own regulations.[150]

The legal and regulatory status of GM foods varies by country, with some nations banning or restricting them, and others permitting them with widely differing degrees of regulation.[151][152][153][154] Some countries allow the import of GM food with authorisation, but either do not allow its cultivation (Russia, Norway, Israel) or have provisions for cultivation even though no GM products are yet produced (Japan, South Korea). Most countries that do not allow GMO cultivation do permit research.[155] Some of the most marked differences occurring between the USA and Europe. The US policy focuses on the product (not the process), only looks at verifiable scientific risks and uses the concept of substantial equivalence.[156] The European Union by contrast has possibly the most stringent GMO regulations in the world.[157] All GMOs, along with irradiated food, are considered “new food” and subject to extensive, case-by-case, science-based food evaluation by the European Food Safety Authority. The criteria for authorisation fall in four broad categories: “safety,” “freedom of choice,” “labelling,” and “traceability.”[158] The level of regulation in other countries that cultivate GMOs lie in between Europe and the United States.

One of the key issues concerning regulators is whether GM products should be labeled. The European Commission says that mandatory labeling and traceability are needed to allow for informed choice, avoid potential false advertising[169] and facilitate the withdrawal of products if adverse effects on health or the environment are discovered.[170] The American Medical Association[171] and the American Association for the Advancement of Science[172] say that absent scientific evidence of harm even voluntary labeling is misleading and will falsely alarm consumers. Labeling of GMO products in the marketplace is required in 64 countries.[173] Labeling can be mandatory up to a threshold GM content level (which varies between countries) or voluntary. In Canada and the USA labeling of GM food is voluntary,[174] while in Europe all food (including processed food) or feed which contains greater than 0.9% of approved GMOs must be labelled.[157]

Critics have objected to the use of genetic engineering on several grounds, that include ethical, ecological and economic concerns. Many of these concerns involve GM crops and whether food produced from them is safe and what impact growing them will have on the environment. These controversies have led to litigation, international trade disputes, and protests, and to restrictive regulation of commercial products in some countries.[175]

Accusations that scientists are “playing God” and other religious issues have been ascribed to the technology from the beginning.[176] Other ethical issues raised include the patenting of life,[177] the use of intellectual property rights,[178] the level of labeling on products,[179][180] control of the food supply[181] and the objectivity of the regulatory process.[182] Although doubts have been raised,[183] economically most studies have found growing GM crops to be beneficial to farmers.[184][185][186]

Gene flow between GM crops and compatible plants, along with increased use of selective herbicides, can increase the risk of “superweeds” developing.[187] Other environmental concerns involve potential impacts on non-target organisms, including soil microbes,[188] and an increase in secondary and resistant insect pests.[189][190] Many of the environmental impacts regarding GM crops may take many years to be understood and are also evident in conventional agriculture practices.[188][191] With the commercialisation of genetically modified fish there are concerns over what the environmental consequences will be if they escape.[192]

There are three main concerns over the safety of genetically modified food: whether they may provoke an allergic reaction; whether the genes could transfer from the food into human cells; and whether the genes not approved for human consumption could outcross to other crops.[193] There is a scientific consensus[194][195][196][197] that currently available food derived from GM crops poses no greater risk to human health than conventional food,[198][199][200][201][202] but that each GM food needs to be tested on a case-by-case basis before introduction.[203][204][205] Nonetheless, members of the public are much less likely than scientists to perceive GM foods as safe.[206][207][208][209]

The literature about Biodiversity and the GE food/feed consumption has sometimes resulted in animated debate regarding the suitability of the experimental designs, the choice of the statistical methods or the public accessibility of data. Such debate, even if positive and part of the natural process of review by the scientific community, has frequently been distorted by the media and often used politically and inappropriately in anti-GE crops campaigns.

Panchin, Alexander Y.; Tuzhikov, Alexander I. (14 January 2016). “Published GMO studies find no evidence of harm when corrected for multiple comparisons”. Critical Reviews in Biotechnology: 15. doi:10.3109/07388551.2015.1130684. ISSN0738-8551. PMID26767435. Here, we show that a number of articles some of which have strongly and negatively influenced the public opinion on GM crops and even provoked political actions, such as GMO embargo, share common flaws in the statistical evaluation of the data. Having accounted for these flaws, we conclude that the data presented in these articles does not provide any substantial evidence of GMO harm.

The presented articles suggesting possible harm of GMOs received high public attention. However, despite their claims, they actually weaken the evidence for the harm and lack of substantial equivalency of studied GMOs. We emphasize that with over 1783 published articles on GMOs over the last 10 years it is expected that some of them should have reported undesired differences between GMOs and conventional crops even if no such differences exist in reality.and

Yang, Y.T.; Chen, B. (2016). “Governing GMOs in the USA: science, law and public health”. Journal of the Science of Food and Agriculture. 96: 18511855. doi:10.1002/jsfa.7523. PMID26536836. It is therefore not surprising that efforts to require labeling and to ban GMOs have been a growing political issue in the USA (citing Domingo and Bordonaba, 2011).

Overall, a broad scientific consensus holds that currently marketed GM food poses no greater risk than conventional food… Major national and international science and medical associations have stated that no adverse human health effects related to GMO food have been reported or substantiated in peer-reviewed literature to date.

Despite various concerns, today, the American Association for the Advancement of Science, the World Health Organization, and many independent international science organizations agree that GMOs are just as safe as other foods. Compared with conventional breeding techniques, genetic engineering is far more precise and, in most cases, less likely to create an unexpected outcome.

GM foods currently available on the international market have passed safety assessments and are not likely to present risks for human health. In addition, no effects on human health have been shown as a result of the consumption of such foods by the general population in the countries where they have been approved. Continuous application of safety assessments based on the Codex Alimentarius principles and, where appropriate, adequate post market monitoring, should form the basis for ensuring the safety of GM foods.

“Genetically modified foods and health: a second interim statement” (PDF). British Medical Association. March 2004. Retrieved 21 March 2016. In our view, the potential for GM foods to cause harmful health effects is very small and many of the concerns expressed apply with equal vigour to conventionally derived foods. However, safety concerns cannot, as yet, be dismissed completely on the basis of information currently available.

When seeking to optimise the balance between benefits and risks, it is prudent to err on the side of caution and, above all, learn from accumulating knowledge and experience. Any new technology such as genetic modification must be examined for possible benefits and risks to human health and the environment. As with all novel foods, safety assessments in relation to GM foods must be made on a case-by-case basis.

Members of the GM jury project were briefed on various aspects of genetic modification by a diverse group of acknowledged experts in the relevant subjects. The GM jury reached the conclusion that the sale of GM foods currently available should be halted and the moratorium on commercial growth of GM crops should be continued. These conclusions were based on the precautionary principle and lack of evidence of any benefit. The Jury expressed concern over the impact of GM crops on farming, the environment, food safety and other potential health effects.

The Royal Society review (2002) concluded that the risks to human health associated with the use of specific viral DNA sequences in GM plants are negligible, and while calling for caution in the introduction of potential allergens into food crops, stressed the absence of evidence that commercially available GM foods cause clinical allergic manifestations. The BMA shares the view that that there is no robust evidence to prove that GM foods are unsafe but we endorse the call for further research and surveillance to provide convincing evidence of safety and benefit.

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Genetic engineering – Wikipedia

Gene therapy – Wikipedia

In the medicine field, gene therapy (also called human gene transfer) is the therapeutic delivery of nucleic acid into a patient’s cells as a drug to treat disease.[1][2] The first attempt at modifying human DNA was performed in 1980 by Martin Cline, but the first successful nuclear gene transfer in humans, approved by the National Institutes of Health, was performed in May 1989.[3] The first therapeutic use of gene transfer as well as the first direct insertion of human DNA into the nuclear genome was performed by French Anderson in a trial starting in September 1990.

Between 1989 and February 2016, over 2,300 clinical trials had been conducted, more than half of them in phase I.[4]

Not all medical procedures that introduce alterations to a patient’s genetic makeup can be considered gene therapy. Bone marrow transplantation and organ transplants in general have been found to introduce foreign DNA into patients.[5] Gene therapy is defined by the precision of the procedure and the intention of direct therapeutic effect.

Gene therapy was conceptualized in 1972, by authors who urged caution before commencing human gene therapy studies.

The first attempt, an unsuccessful one, at gene therapy (as well as the first case of medical transfer of foreign genes into humans not counting organ transplantation) was performed by Martin Cline on 10 July 1980.[6][7] Cline claimed that one of the genes in his patients was active six months later, though he never published this data or had it verified[8] and even if he is correct, it’s unlikely it produced any significant beneficial effects treating beta-thalassemia.

After extensive research on animals throughout the 1980s and a 1989 bacterial gene tagging trial on humans, the first gene therapy widely accepted as a success was demonstrated in a trial that started on 14 September 1990, when Ashi DeSilva was treated for ADA-SCID.[9]

The first somatic treatment that produced a permanent genetic change was performed in 1993.[citation needed]

Gene therapy is a way to fix a genetic problem at its source. The polymers are either translated into proteins, interfere with target gene expression, or possibly correct genetic mutations.

The most common form uses DNA that encodes a functional, therapeutic gene to replace a mutated gene. The polymer molecule is packaged within a “vector”, which carries the molecule inside cells.

Early clinical failures led to dismissals of gene therapy. Clinical successes since 2006 regained researchers’ attention, although as of 2014[update], it was still largely an experimental technique.[10] These include treatment of retinal diseases Leber’s congenital amaurosis[11][12][13][14] and choroideremia,[15] X-linked SCID,[16] ADA-SCID,[17][18] adrenoleukodystrophy,[19] chronic lymphocytic leukemia (CLL),[20] acute lymphocytic leukemia (ALL),[21] multiple myeloma,[22] haemophilia,[18] and Parkinson’s disease.[23] Between 2013 and April 2014, US companies invested over $600 million in the field.[24]

The first commercial gene therapy, Gendicine, was approved in China in 2003 for the treatment of certain cancers.[25] In 2011 Neovasculgen was registered in Russia as the first-in-class gene-therapy drug for treatment of peripheral artery disease, including critical limb ischemia.[26]In 2012 Glybera, a treatment for a rare inherited disorder, became the first treatment to be approved for clinical use in either Europe or the United States after its endorsement by the European Commission.[10][27]

Following early advances in genetic engineering of bacteria, cells, and small animals, scientists started considering how to apply it to medicine. Two main approaches were considered replacing or disrupting defective genes.[28] Scientists focused on diseases caused by single-gene defects, such as cystic fibrosis, haemophilia, muscular dystrophy, thalassemia, and sickle cell anemia. Glybera treats one such disease, caused by a defect in lipoprotein lipase.[27]

DNA must be administered, reach the damaged cells, enter the cell and either express or disrupt a protein.[29] Multiple delivery techniques have been explored. The initial approach incorporated DNA into an engineered virus to deliver the DNA into a chromosome.[30][31] Naked DNA approaches have also been explored, especially in the context of vaccine development.[32]

Generally, efforts focused on administering a gene that causes a needed protein to be expressed. More recently, increased understanding of nuclease function has led to more direct DNA editing, using techniques such as zinc finger nucleases and CRISPR. The vector incorporates genes into chromosomes. The expressed nucleases then knock out and replace genes in the chromosome. As of 2014[update] these approaches involve removing cells from patients, editing a chromosome and returning the transformed cells to patients.[33]

Gene editing is a potential approach to alter the human genome to treat genetic diseases,[34] viral diseases,[35] and cancer.[36] As of 2016[update] these approaches were still years from being medicine.[37][38]

Gene therapy may be classified into two types:

In somatic cell gene therapy (SCGT), the therapeutic genes are transferred into any cell other than a gamete, germ cell, gametocyte, or undifferentiated stem cell. Any such modifications affect the individual patient only, and are not inherited by offspring. Somatic gene therapy represents mainstream basic and clinical research, in which therapeutic DNA (either integrated in the genome or as an external episome or plasmid) is used to treat disease.

Over 600 clinical trials utilizing SCGT are underway[when?] in the US. Most focus on severe genetic disorders, including immunodeficiencies, haemophilia, thalassaemia, and cystic fibrosis. Such single gene disorders are good candidates for somatic cell therapy. The complete correction of a genetic disorder or the replacement of multiple genes is not yet possible. Only a few of the trials are in the advanced stages.[39]

In germline gene therapy (GGT), germ cells (sperm or egg cells) are modified by the introduction of functional genes into their genomes. Modifying a germ cell causes all the organism’s cells to contain the modified gene. The change is therefore heritable and passed on to later generations. Australia, Canada, Germany, Israel, Switzerland, and the Netherlands[40] prohibit GGT for application in human beings, for technical and ethical reasons, including insufficient knowledge about possible risks to future generations[40] and higher risks versus SCGT.[41] The US has no federal controls specifically addressing human genetic modification (beyond FDA regulations for therapies in general).[40][42][43][44]

The delivery of DNA into cells can be accomplished by multiple methods. The two major classes are recombinant viruses (sometimes called biological nanoparticles or viral vectors) and naked DNA or DNA complexes (non-viral methods).

In order to replicate, viruses introduce their genetic material into the host cell, tricking the host’s cellular machinery into using it as blueprints for viral proteins. Retroviruses go a stage further by having their genetic material copied into the genome of the host cell. Scientists exploit this by substituting a virus’s genetic material with therapeutic DNA. (The term ‘DNA’ may be an oversimplification, as some viruses contain RNA, and gene therapy could take this form as well.) A number of viruses have been used for human gene therapy, including retroviruses, adenoviruses, herpes simplex, vaccinia, and adeno-associated virus.[4] Like the genetic material (DNA or RNA) in viruses, therapeutic DNA can be designed to simply serve as a temporary blueprint that is degraded naturally or (at least theoretically) to enter the host’s genome, becoming a permanent part of the host’s DNA in infected cells.

Non-viral methods present certain advantages over viral methods, such as large scale production and low host immunogenicity. However, non-viral methods initially produced lower levels of transfection and gene expression, and thus lower therapeutic efficacy. Later technology remedied this deficiency.[citation needed]

Methods for non-viral gene therapy include the injection of naked DNA, electroporation, the gene gun, sonoporation, magnetofection, the use of oligonucleotides, lipoplexes, dendrimers, and inorganic nanoparticles.

Some of the unsolved problems include:

Three patients’ deaths have been reported in gene therapy trials, putting the field under close scrutiny. The first was that of Jesse Gelsinger, who died in 1999 because of immune rejection response.[51] One X-SCID patient died of leukemia in 2003.[9] In 2007, a rheumatoid arthritis patient died from an infection; the subsequent investigation concluded that the death was not related to gene therapy.[52]

In 1972 Friedmann and Roblin authored a paper in Science titled “Gene therapy for human genetic disease?”[53] Rogers (1970) was cited for proposing that exogenous good DNA be used to replace the defective DNA in those who suffer from genetic defects.[54]

In 1984 a retrovirus vector system was designed that could efficiently insert foreign genes into mammalian chromosomes.[55]

The first approved gene therapy clinical research in the US took place on 14 September 1990, at the National Institutes of Health (NIH), under the direction of William French Anderson.[56] Four-year-old Ashanti DeSilva received treatment for a genetic defect that left her with ADA-SCID, a severe immune system deficiency. The defective gene of the patient’s blood cells was replaced by the functional variant. Ashantis immune system was partially restored by the therapy. Production of the missing enzyme was temporarily stimulated, but the new cells with functional genes were not generated. She led a normal life only with the regular injections performed every two months. The effects were successful, but temporary.[57]

Cancer gene therapy was introduced in 1992/93 (Trojan et al. 1993).[58] The treatment of glioblastoma multiforme, the malignant brain tumor whose outcome is always fatal, was done using a vector expressing antisense IGF-I RNA (clinical trial approved by NIH protocolno.1602 November 24, 1993,[59] and by the FDA in 1994). This therapy also represents the beginning of cancer immunogene therapy, a treatment which proves to be effective due to the anti-tumor mechanism of IGF-I antisense, which is related to strong immune and apoptotic phenomena.

In 1992 Claudio Bordignon, working at the Vita-Salute San Raffaele University, performed the first gene therapy procedure using hematopoietic stem cells as vectors to deliver genes intended to correct hereditary diseases.[60] In 2002 this work led to the publication of the first successful gene therapy treatment for adenosine deaminase deficiency (ADA-SCID). The success of a multi-center trial for treating children with SCID (severe combined immune deficiency or “bubble boy” disease) from 2000 and 2002, was questioned when two of the ten children treated at the trial’s Paris center developed a leukemia-like condition. Clinical trials were halted temporarily in 2002, but resumed after regulatory review of the protocol in the US, the United Kingdom, France, Italy, and Germany.[61]

In 1993 Andrew Gobea was born with SCID following prenatal genetic screening. Blood was removed from his mother’s placenta and umbilical cord immediately after birth, to acquire stem cells. The allele that codes for adenosine deaminase (ADA) was obtained and inserted into a retrovirus. Retroviruses and stem cells were mixed, after which the viruses inserted the gene into the stem cell chromosomes. Stem cells containing the working ADA gene were injected into Andrew’s blood. Injections of the ADA enzyme were also given weekly. For four years T cells (white blood cells), produced by stem cells, made ADA enzymes using the ADA gene. After four years more treatment was needed.[62]

Jesse Gelsinger’s death in 1999 impeded gene therapy research in the US.[63][64] As a result, the FDA suspended several clinical trials pending the reevaluation of ethical and procedural practices.[65]

The modified cancer gene therapy strategy of antisense IGF-I RNA (NIH n 1602)[59] using antisense / triple helix anti-IGF-I approach was registered in 2002 by Wiley gene therapy clinical trial – n 635 and 636. The approach has shown promising results in the treatment of six different malignant tumors: glioblastoma, cancers of liver, colon, prostate, uterus, and ovary (Collaborative NATO Science Programme on Gene Therapy USA, France, Poland n LST 980517 conducted by J. Trojan) (Trojan et al., 2012). This anti-gene antisense/triple helix therapy has proven to be efficient, due to the mechanism stopping simultaneously IGF-I expression on translation and transcription levels, strengthening anti-tumor immune and apoptotic phenomena.

Sickle-cell disease can be treated in mice.[66] The mice which have essentially the same defect that causes human cases used a viral vector to induce production of fetal hemoglobin (HbF), which normally ceases to be produced shortly after birth. In humans, the use of hydroxyurea to stimulate the production of HbF temporarily alleviates sickle cell symptoms. The researchers demonstrated this treatment to be a more permanent means to increase therapeutic HbF production.[67]

A new gene therapy approach repaired errors in messenger RNA derived from defective genes. This technique has the potential to treat thalassaemia, cystic fibrosis and some cancers.[68]

Researchers created liposomes 25 nanometers across that can carry therapeutic DNA through pores in the nuclear membrane.[69]

In 2003 a research team inserted genes into the brain for the first time. They used liposomes coated in a polymer called polyethylene glycol, which unlike viral vectors, are small enough to cross the bloodbrain barrier.[70]

Short pieces of double-stranded RNA (short, interfering RNAs or siRNAs) are used by cells to degrade RNA of a particular sequence. If a siRNA is designed to match the RNA copied from a faulty gene, then the abnormal protein product of that gene will not be produced.[71]

Gendicine is a cancer gene therapy that delivers the tumor suppressor gene p53 using an engineered adenovirus. In 2003, it was approved in China for the treatment of head and neck squamous cell carcinoma.[25]

In March researchers announced the successful use of gene therapy to treat two adult patients for X-linked chronic granulomatous disease, a disease which affects myeloid cells and damages the immune system. The study is the first to show that gene therapy can treat the myeloid system.[72]

In May a team reported a way to prevent the immune system from rejecting a newly delivered gene.[73] Similar to organ transplantation, gene therapy has been plagued by this problem. The immune system normally recognizes the new gene as foreign and rejects the cells carrying it. The research utilized a newly uncovered network of genes regulated by molecules known as microRNAs. This natural function selectively obscured their therapeutic gene in immune system cells and protected it from discovery. Mice infected with the gene containing an immune-cell microRNA target sequence did not reject the gene.

In August scientists successfully treated metastatic melanoma in two patients using killer T cells genetically retargeted to attack the cancer cells.[74]

In November researchers reported on the use of VRX496, a gene-based immunotherapy for the treatment of HIV that uses a lentiviral vector to deliver an antisense gene against the HIV envelope. In a phase I clinical trial, five subjects with chronic HIV infection who had failed to respond to at least two antiretroviral regimens were treated. A single intravenous infusion of autologous CD4 T cells genetically modified with VRX496 was well tolerated. All patients had stable or decreased viral load; four of the five patients had stable or increased CD4 T cell counts. All five patients had stable or increased immune response to HIV antigens and other pathogens. This was the first evaluation of a lentiviral vector administered in a US human clinical trial.[75][76]

In May researchers announced the first gene therapy trial for inherited retinal disease. The first operation was carried out on a 23-year-old British male, Robert Johnson, in early 2007.[77]

Leber’s congenital amaurosis is an inherited blinding disease caused by mutations in the RPE65 gene. The results of a small clinical trial in children were published in April.[11] Delivery of recombinant adeno-associated virus (AAV) carrying RPE65 yielded positive results. In May two more groups reported positive results in independent clinical trials using gene therapy to treat the condition. In all three clinical trials, patients recovered functional vision without apparent side-effects.[11][12][13][14]

In September researchers were able to give trichromatic vision to squirrel monkeys.[78] In November 2009, researchers halted a fatal genetic disorder called adrenoleukodystrophy in two children using a lentivirus vector to deliver a functioning version of ABCD1, the gene that is mutated in the disorder.[79]

An April paper reported that gene therapy addressed achromatopsia (color blindness) in dogs by targeting cone photoreceptors. Cone function and day vision were restored for at least 33 months in two young specimens. The therapy was less efficient for older dogs.[80]

In September it was announced that an 18-year-old male patient in France with beta-thalassemia major had been successfully treated.[81] Beta-thalassemia major is an inherited blood disease in which beta haemoglobin is missing and patients are dependent on regular lifelong blood transfusions.[82] The technique used a lentiviral vector to transduce the human -globin gene into purified blood and marrow cells obtained from the patient in June 2007.[83] The patient’s haemoglobin levels were stable at 9 to 10 g/dL. About a third of the hemoglobin contained the form introduced by the viral vector and blood transfusions were not needed.[83][84] Further clinical trials were planned.[85] Bone marrow transplants are the only cure for thalassemia, but 75% of patients do not find a matching donor.[84]

Cancer immunogene therapy using modified antigene, antisense/triple helix approach was introduced in South America in 2010/11 in La Sabana University, Bogota (Ethical Committee 14 December 2010, no P-004-10). Considering the ethical aspect of gene diagnostic and gene therapy targeting IGF-I, the IGF-I expressing tumors i.e. lung and epidermis cancers were treated (Trojan et al. 2016).[86][87]

In 2007 and 2008, a man (Timothy Ray Brown) was cured of HIV by repeated hematopoietic stem cell transplantation (see also allogeneic stem cell transplantation, allogeneic bone marrow transplantation, allotransplantation) with double-delta-32 mutation which disables the CCR5 receptor. This cure was accepted by the medical community in 2011.[88] It required complete ablation of existing bone marrow, which is very debilitating.

In August two of three subjects of a pilot study were confirmed to have been cured from chronic lymphocytic leukemia (CLL). The therapy used genetically modified T cells to attack cells that expressed the CD19 protein to fight the disease.[20] In 2013, the researchers announced that 26 of 59 patients had achieved complete remission and the original patient had remained tumor-free.[89]

Human HGF plasmid DNA therapy of cardiomyocytes is being examined as a potential treatment for coronary artery disease as well as treatment for the damage that occurs to the heart after myocardial infarction.[90][91]

In 2011 Neovasculgen was registered in Russia as the first-in-class gene-therapy drug for treatment of peripheral artery disease, including critical limb ischemia; it delivers the gene encoding for VEGF.[92][26] Neovasculogen is a plasmid encoding the CMV promoter and the 165 amino acid form of VEGF.[93][94]

The FDA approved Phase 1 clinical trials on thalassemia major patients in the US for 10 participants in July.[95] The study was expected to continue until 2015.[85]

In July 2012, the European Medicines Agency recommended approval of a gene therapy treatment for the first time in either Europe or the United States. The treatment used Alipogene tiparvovec (Glybera) to compensate for lipoprotein lipase deficiency, which can cause severe pancreatitis.[96] The recommendation was endorsed by the European Commission in November 2012[10][27][97][98] and commercial rollout began in late 2014.[99] Alipogene tiparvovec was expected to cost around $1.6 million per treatment in 2012,[100] revised to $1 million in 2015,[101] making it the most expensive medicine in the world at the time.[102] As of 2016[update], only one person had been treated with drug.[103]

In December 2012, it was reported that 10 of 13 patients with multiple myeloma were in remission “or very close to it” three months after being injected with a treatment involving genetically engineered T cells to target proteins NY-ESO-1 and LAGE-1, which exist only on cancerous myeloma cells.[22]

In March researchers reported that three of five adult subjects who had acute lymphocytic leukemia (ALL) had been in remission for five months to two years after being treated with genetically modified T cells which attacked cells with CD19 genes on their surface, i.e. all B-cells, cancerous or not. The researchers believed that the patients’ immune systems would make normal T-cells and B-cells after a couple of months. They were also given bone marrow. One patient relapsed and died and one died of a blood clot unrelated to the disease.[21]

Following encouraging Phase 1 trials, in April, researchers announced they were starting Phase 2 clinical trials (called CUPID2 and SERCA-LVAD) on 250 patients[104] at several hospitals to combat heart disease. The therapy was designed to increase the levels of SERCA2, a protein in heart muscles, improving muscle function.[105] The FDA granted this a Breakthrough Therapy Designation to accelerate the trial and approval process.[106] In 2016 it was reported that no improvement was found from the CUPID 2 trial.[107]

In July researchers reported promising results for six children with two severe hereditary diseases had been treated with a partially deactivated lentivirus to replace a faulty gene and after 732 months. Three of the children had metachromatic leukodystrophy, which causes children to lose cognitive and motor skills.[108] The other children had Wiskott-Aldrich syndrome, which leaves them to open to infection, autoimmune diseases, and cancer.[109] Follow up trials with gene therapy on another six children with Wiskott-Aldrich syndrome were also reported as promising.[110][111]

In October researchers reported that two children born with adenosine deaminase severe combined immunodeficiency disease (ADA-SCID) had been treated with genetically engineered stem cells 18 months previously and that their immune systems were showing signs of full recovery. Another three children were making progress.[18] In 2014 a further 18 children with ADA-SCID were cured by gene therapy.[112] ADA-SCID children have no functioning immune system and are sometimes known as “bubble children.”[18]

Also in October researchers reported that they had treated six hemophilia sufferers in early 2011 using an adeno-associated virus. Over two years later all six were producing clotting factor.[18][113]

In January researchers reported that six choroideremia patients had been treated with adeno-associated virus with a copy of REP1. Over a six-month to two-year period all had improved their sight.[114][115] By 2016, 32 patients had been treated with positive results and researchers were hopeful the treatment would be long-lasting.[15] Choroideremia is an inherited genetic eye disease with no approved treatment, leading to loss of sight.

In March researchers reported that 12 HIV patients had been treated since 2009 in a trial with a genetically engineered virus with a rare mutation (CCR5 deficiency) known to protect against HIV with promising results.[116][117]

Clinical trials of gene therapy for sickle cell disease were started in 2014.[118][119] There is a need for high quality randomised controlled trials assessing the risks and benefits involved with gene therapy for people with sickle cell disease.[120]

In February LentiGlobin BB305, a gene therapy treatment undergoing clinical trials for treatment of beta thalassemia gained FDA “breakthrough” status after several patients were able to forgo the frequent blood transfusions usually required to treat the disease.[121]

In March researchers delivered a recombinant gene encoding a broadly neutralizing antibody into monkeys infected with simian HIV; the monkeys’ cells produced the antibody, which cleared them of HIV. The technique is named immunoprophylaxis by gene transfer (IGT). Animal tests for antibodies to ebola, malaria, influenza, and hepatitis were underway.[122][123]

In March, scientists, including an inventor of CRISPR, Jennifer Doudna, urged a worldwide moratorium on germline gene therapy, writing “scientists should avoid even attempting, in lax jurisdictions, germline genome modification for clinical application in humans” until the full implications “are discussed among scientific and governmental organizations”.[124][125][126][127]

In October, researchers announced that they had treated a baby girl, Layla Richards, with an experimental treatment using donor T-cells genetically engineered using TALEN to attack cancer cells. One year after the treatment she was still free of her cancer (a highly aggressive form of acute lymphoblastic leukaemia [ALL]).[128] Children with highly aggressive ALL normally have a very poor prognosis and Layla’s disease had been regarded as terminal before the treatment.[129]

In December, scientists of major world academies called for a moratorium on inheritable human genome edits, including those related to CRISPR-Cas9 technologies[130] but that basic research including embryo gene editing should continue.[131]

In April the Committee for Medicinal Products for Human Use of the European Medicines Agency endorsed a gene therapy treatment called Strimvelis[132][133] and the European Commission approved it in June.[134] This treats children born with adenosine deaminase deficiency and who have no functioning immune system. This was the second gene therapy treatment to be approved in Europe.[135]

In October, Chinese scientists reported they had started a trial to genetically modify T-cells from 10 adult patients with lung cancer and reinject the modified T-cells back into their bodies to attack the cancer cells. The T-cells had the PD-1 protein (which stops or slows the immune response) removed using CRISPR-Cas9.[136][137]

A 2016 Cochrane systematic review looking at data from four trials on topical cystic fibrosis transmembrane conductance regulator (CFTR) gene therapy does not support its clinical use as a mist inhaled into the lungs to treat cystic fibrosis patients with lung infections. One of the four trials did find weak evidence that liposome-based CFTR gene transfer therapy may lead to a small respiratory improvement for people with CF. This weak evidence is not enough to make a clinical recommendation for routine CFTR gene therapy.[138]

In February Kite Pharma announced results from a clinical trial of CAR-T cells in around a hundred people with advanced Non-Hodgkin lymphoma.[139]

In March, French scientists reported on clinical research of gene therapy to treat sickle-cell disease.[140]

In August, the FDA approved tisagenlecleucel for acute lymphoblastic leukemia.[141] Tisagenlecleucel is an adoptive cell transfer therapy for B-cell acute lymphoblastic leukemia; T cells from a person with cancer are removed, genetically engineered to make a specific T-cell receptor (a chimeric T cell receptor, or “CAR-T”) that reacts to the cancer, and are administered back to the person. The T cells are engineered to target a protein called CD19 that is common on B cells. This is the first form of gene therapy to be approved in the United States. In October, a similar therapy called axicabtagene ciloleucel was approved for non-Hodgkin lymphoma.[142]

In December the results of using an adeno-associated virus with blood clotting factor VIII to treat nine haemophilia A patients were published. Six of the seven patients on the high dose regime increased the level of the blood clotting VIII to normal levels. The low and medium dose regimes had no effect on the patient’s blood clotting levels.[143][144]

In December, the FDA approved Luxturna, the first in vivo gene therapy, for the treatment of blindness due to Leber’s congenital amaurosis.[145] The price of this treatment was 850,000 US dollars for both eyes.[146][147]

Speculated uses for gene therapy include:

Athletes might adopt gene therapy technologies to improve their performance.[148] Gene doping is not known to occur, but multiple gene therapies may have such effects. Kayser et al. argue that gene doping could level the playing field if all athletes receive equal access. Critics claim that any therapeutic intervention for non-therapeutic/enhancement purposes compromises the ethical foundations of medicine and sports.[149]

Genetic engineering could be used to cure diseases, but also to change physical appearance, metabolism, and even improve physical capabilities and mental faculties such as memory and intelligence. Ethical claims about germline engineering include beliefs that every fetus has a right to remain genetically unmodified, that parents hold the right to genetically modify their offspring, and that every child has the right to be born free of preventable diseases.[150][151][152] For parents, genetic engineering could be seen as another child enhancement technique to add to diet, exercise, education, training, cosmetics, and plastic surgery.[153][154] Another theorist claims that moral concerns limit but do not prohibit germline engineering.[155]

Possible regulatory schemes include a complete ban, provision to everyone, or professional self-regulation. The American Medical Associations Council on Ethical and Judicial Affairs stated that “genetic interventions to enhance traits should be considered permissible only in severely restricted situations: (1) clear and meaningful benefits to the fetus or child; (2) no trade-off with other characteristics or traits; and (3) equal access to the genetic technology, irrespective of income or other socioeconomic characteristics.”[156]

As early in the history of biotechnology as 1990, there have been scientists opposed to attempts to modify the human germline using these new tools,[157] and such concerns have continued as technology progressed.[158][159] With the advent of new techniques like CRISPR, in March 2015 a group of scientists urged a worldwide moratorium on clinical use of gene editing technologies to edit the human genome in a way that can be inherited.[124][125][126][127] In April 2015, researchers sparked controversy when they reported results of basic research to edit the DNA of non-viable human embryos using CRISPR.[160][161] A committee of the American National Academy of Sciences and National Academy of Medicine gave qualified support to human genome editing in 2017[162][163] once answers have been found to safety and efficiency problems “but only for serious conditions under stringent oversight.”[164]

Regulations covering genetic modification are part of general guidelines about human-involved biomedical research. There are no international treaties which are legally binding in this area, but there are recommendations for national laws from various bodies.

The Helsinki Declaration (Ethical Principles for Medical Research Involving Human Subjects) was amended by the World Medical Association’s General Assembly in 2008. This document provides principles physicians and researchers must consider when involving humans as research subjects. The Statement on Gene Therapy Research initiated by the Human Genome Organization (HUGO) in 2001 provides a legal baseline for all countries. HUGOs document emphasizes human freedom and adherence to human rights, and offers recommendations for somatic gene therapy, including the importance of recognizing public concerns about such research.[165]

No federal legislation lays out protocols or restrictions about human genetic engineering. This subject is governed by overlapping regulations from local and federal agencies, including the Department of Health and Human Services, the FDA and NIH’s Recombinant DNA Advisory Committee. Researchers seeking federal funds for an investigational new drug application, (commonly the case for somatic human genetic engineering,) must obey international and federal guidelines for the protection of human subjects.[166]

NIH serves as the main gene therapy regulator for federally funded research. Privately funded research is advised to follow these regulations. NIH provides funding for research that develops or enhances genetic engineering techniques and to evaluate the ethics and quality in current research. The NIH maintains a mandatory registry of human genetic engineering research protocols that includes all federally funded projects.

An NIH advisory committee published a set of guidelines on gene manipulation.[167] The guidelines discuss lab safety as well as human test subjects and various experimental types that involve genetic changes. Several sections specifically pertain to human genetic engineering, including Section III-C-1. This section describes required review processes and other aspects when seeking approval to begin clinical research involving genetic transfer into a human patient.[168] The protocol for a gene therapy clinical trial must be approved by the NIH’s Recombinant DNA Advisory Committee prior to any clinical trial beginning; this is different from any other kind of clinical trial.[167]

As with other kinds of drugs, the FDA regulates the quality and safety of gene therapy products and supervises how these products are used clinically. Therapeutic alteration of the human genome falls under the same regulatory requirements as any other medical treatment. Research involving human subjects, such as clinical trials, must be reviewed and approved by the FDA and an Institutional Review Board.[169][170]

Gene therapy is the basis for the plotline of the film I Am Legend[171] and the TV show Will Gene Therapy Change the Human Race?.[172] In 1994, gene therapy was a plot element in The Erlenmeyer Flask, The X-Files’ first-season finale. It is also used in Stargate as a means of allowing humans to use Ancient technology.[173]

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Gene therapy – Wikipedia

Gene therapy – Wikipedia

In the medicine field, gene therapy (also called human gene transfer) is the therapeutic delivery of nucleic acid into a patient’s cells as a drug to treat disease.[1][2] The first attempt at modifying human DNA was performed in 1980 by Martin Cline, but the first successful nuclear gene transfer in humans, approved by the National Institutes of Health, was performed in May 1989.[3] The first therapeutic use of gene transfer as well as the first direct insertion of human DNA into the nuclear genome was performed by French Anderson in a trial starting in September 1990.

Between 1989 and February 2016, over 2,300 clinical trials had been conducted, more than half of them in phase I.[4]

Not all medical procedures that introduce alterations to a patient’s genetic makeup can be considered gene therapy. Bone marrow transplantation and organ transplants in general have been found to introduce foreign DNA into patients.[5] Gene therapy is defined by the precision of the procedure and the intention of direct therapeutic effect.

Gene therapy was conceptualized in 1972, by authors who urged caution before commencing human gene therapy studies.

The first attempt, an unsuccessful one, at gene therapy (as well as the first case of medical transfer of foreign genes into humans not counting organ transplantation) was performed by Martin Cline on 10 July 1980.[6][7] Cline claimed that one of the genes in his patients was active six months later, though he never published this data or had it verified[8] and even if he is correct, it’s unlikely it produced any significant beneficial effects treating beta-thalassemia.

After extensive research on animals throughout the 1980s and a 1989 bacterial gene tagging trial on humans, the first gene therapy widely accepted as a success was demonstrated in a trial that started on 14 September 1990, when Ashi DeSilva was treated for ADA-SCID.[9]

The first somatic treatment that produced a permanent genetic change was performed in 1993.[citation needed]

Gene therapy is a way to fix a genetic problem at its source. The polymers are either translated into proteins, interfere with target gene expression, or possibly correct genetic mutations.

The most common form uses DNA that encodes a functional, therapeutic gene to replace a mutated gene. The polymer molecule is packaged within a “vector”, which carries the molecule inside cells.

Early clinical failures led to dismissals of gene therapy. Clinical successes since 2006 regained researchers’ attention, although as of 2014[update], it was still largely an experimental technique.[10] These include treatment of retinal diseases Leber’s congenital amaurosis[11][12][13][14] and choroideremia,[15] X-linked SCID,[16] ADA-SCID,[17][18] adrenoleukodystrophy,[19] chronic lymphocytic leukemia (CLL),[20] acute lymphocytic leukemia (ALL),[21] multiple myeloma,[22] haemophilia,[18] and Parkinson’s disease.[23] Between 2013 and April 2014, US companies invested over $600 million in the field.[24]

The first commercial gene therapy, Gendicine, was approved in China in 2003 for the treatment of certain cancers.[25] In 2011 Neovasculgen was registered in Russia as the first-in-class gene-therapy drug for treatment of peripheral artery disease, including critical limb ischemia.[26]In 2012 Glybera, a treatment for a rare inherited disorder, became the first treatment to be approved for clinical use in either Europe or the United States after its endorsement by the European Commission.[10][27]

Following early advances in genetic engineering of bacteria, cells, and small animals, scientists started considering how to apply it to medicine. Two main approaches were considered replacing or disrupting defective genes.[28] Scientists focused on diseases caused by single-gene defects, such as cystic fibrosis, haemophilia, muscular dystrophy, thalassemia, and sickle cell anemia. Glybera treats one such disease, caused by a defect in lipoprotein lipase.[27]

DNA must be administered, reach the damaged cells, enter the cell and either express or disrupt a protein.[29] Multiple delivery techniques have been explored. The initial approach incorporated DNA into an engineered virus to deliver the DNA into a chromosome.[30][31] Naked DNA approaches have also been explored, especially in the context of vaccine development.[32]

Generally, efforts focused on administering a gene that causes a needed protein to be expressed. More recently, increased understanding of nuclease function has led to more direct DNA editing, using techniques such as zinc finger nucleases and CRISPR. The vector incorporates genes into chromosomes. The expressed nucleases then knock out and replace genes in the chromosome. As of 2014[update] these approaches involve removing cells from patients, editing a chromosome and returning the transformed cells to patients.[33]

Gene editing is a potential approach to alter the human genome to treat genetic diseases,[34] viral diseases,[35] and cancer.[36] As of 2016[update] these approaches were still years from being medicine.[37][38]

Gene therapy may be classified into two types:

In somatic cell gene therapy (SCGT), the therapeutic genes are transferred into any cell other than a gamete, germ cell, gametocyte, or undifferentiated stem cell. Any such modifications affect the individual patient only, and are not inherited by offspring. Somatic gene therapy represents mainstream basic and clinical research, in which therapeutic DNA (either integrated in the genome or as an external episome or plasmid) is used to treat disease.

Over 600 clinical trials utilizing SCGT are underway[when?] in the US. Most focus on severe genetic disorders, including immunodeficiencies, haemophilia, thalassaemia, and cystic fibrosis. Such single gene disorders are good candidates for somatic cell therapy. The complete correction of a genetic disorder or the replacement of multiple genes is not yet possible. Only a few of the trials are in the advanced stages.[39]

In germline gene therapy (GGT), germ cells (sperm or egg cells) are modified by the introduction of functional genes into their genomes. Modifying a germ cell causes all the organism’s cells to contain the modified gene. The change is therefore heritable and passed on to later generations. Australia, Canada, Germany, Israel, Switzerland, and the Netherlands[40] prohibit GGT for application in human beings, for technical and ethical reasons, including insufficient knowledge about possible risks to future generations[40] and higher risks versus SCGT.[41] The US has no federal controls specifically addressing human genetic modification (beyond FDA regulations for therapies in general).[40][42][43][44]

The delivery of DNA into cells can be accomplished by multiple methods. The two major classes are recombinant viruses (sometimes called biological nanoparticles or viral vectors) and naked DNA or DNA complexes (non-viral methods).

In order to replicate, viruses introduce their genetic material into the host cell, tricking the host’s cellular machinery into using it as blueprints for viral proteins. Retroviruses go a stage further by having their genetic material copied into the genome of the host cell. Scientists exploit this by substituting a virus’s genetic material with therapeutic DNA. (The term ‘DNA’ may be an oversimplification, as some viruses contain RNA, and gene therapy could take this form as well.) A number of viruses have been used for human gene therapy, including retroviruses, adenoviruses, herpes simplex, vaccinia, and adeno-associated virus.[4] Like the genetic material (DNA or RNA) in viruses, therapeutic DNA can be designed to simply serve as a temporary blueprint that is degraded naturally or (at least theoretically) to enter the host’s genome, becoming a permanent part of the host’s DNA in infected cells.

Non-viral methods present certain advantages over viral methods, such as large scale production and low host immunogenicity. However, non-viral methods initially produced lower levels of transfection and gene expression, and thus lower therapeutic efficacy. Later technology remedied this deficiency.[citation needed]

Methods for non-viral gene therapy include the injection of naked DNA, electroporation, the gene gun, sonoporation, magnetofection, the use of oligonucleotides, lipoplexes, dendrimers, and inorganic nanoparticles.

Some of the unsolved problems include:

Three patients’ deaths have been reported in gene therapy trials, putting the field under close scrutiny. The first was that of Jesse Gelsinger, who died in 1999 because of immune rejection response.[51] One X-SCID patient died of leukemia in 2003.[9] In 2007, a rheumatoid arthritis patient died from an infection; the subsequent investigation concluded that the death was not related to gene therapy.[52]

In 1972 Friedmann and Roblin authored a paper in Science titled “Gene therapy for human genetic disease?”[53] Rogers (1970) was cited for proposing that exogenous good DNA be used to replace the defective DNA in those who suffer from genetic defects.[54]

In 1984 a retrovirus vector system was designed that could efficiently insert foreign genes into mammalian chromosomes.[55]

The first approved gene therapy clinical research in the US took place on 14 September 1990, at the National Institutes of Health (NIH), under the direction of William French Anderson.[56] Four-year-old Ashanti DeSilva received treatment for a genetic defect that left her with ADA-SCID, a severe immune system deficiency. The defective gene of the patient’s blood cells was replaced by the functional variant. Ashantis immune system was partially restored by the therapy. Production of the missing enzyme was temporarily stimulated, but the new cells with functional genes were not generated. She led a normal life only with the regular injections performed every two months. The effects were successful, but temporary.[57]

Cancer gene therapy was introduced in 1992/93 (Trojan et al. 1993).[58] The treatment of glioblastoma multiforme, the malignant brain tumor whose outcome is always fatal, was done using a vector expressing antisense IGF-I RNA (clinical trial approved by NIH protocolno.1602 November 24, 1993,[59] and by the FDA in 1994). This therapy also represents the beginning of cancer immunogene therapy, a treatment which proves to be effective due to the anti-tumor mechanism of IGF-I antisense, which is related to strong immune and apoptotic phenomena.

In 1992 Claudio Bordignon, working at the Vita-Salute San Raffaele University, performed the first gene therapy procedure using hematopoietic stem cells as vectors to deliver genes intended to correct hereditary diseases.[60] In 2002 this work led to the publication of the first successful gene therapy treatment for adenosine deaminase deficiency (ADA-SCID). The success of a multi-center trial for treating children with SCID (severe combined immune deficiency or “bubble boy” disease) from 2000 and 2002, was questioned when two of the ten children treated at the trial’s Paris center developed a leukemia-like condition. Clinical trials were halted temporarily in 2002, but resumed after regulatory review of the protocol in the US, the United Kingdom, France, Italy, and Germany.[61]

In 1993 Andrew Gobea was born with SCID following prenatal genetic screening. Blood was removed from his mother’s placenta and umbilical cord immediately after birth, to acquire stem cells. The allele that codes for adenosine deaminase (ADA) was obtained and inserted into a retrovirus. Retroviruses and stem cells were mixed, after which the viruses inserted the gene into the stem cell chromosomes. Stem cells containing the working ADA gene were injected into Andrew’s blood. Injections of the ADA enzyme were also given weekly. For four years T cells (white blood cells), produced by stem cells, made ADA enzymes using the ADA gene. After four years more treatment was needed.[62]

Jesse Gelsinger’s death in 1999 impeded gene therapy research in the US.[63][64] As a result, the FDA suspended several clinical trials pending the reevaluation of ethical and procedural practices.[65]

The modified cancer gene therapy strategy of antisense IGF-I RNA (NIH n 1602)[59] using antisense / triple helix anti-IGF-I approach was registered in 2002 by Wiley gene therapy clinical trial – n 635 and 636. The approach has shown promising results in the treatment of six different malignant tumors: glioblastoma, cancers of liver, colon, prostate, uterus, and ovary (Collaborative NATO Science Programme on Gene Therapy USA, France, Poland n LST 980517 conducted by J. Trojan) (Trojan et al., 2012). This anti-gene antisense/triple helix therapy has proven to be efficient, due to the mechanism stopping simultaneously IGF-I expression on translation and transcription levels, strengthening anti-tumor immune and apoptotic phenomena.

Sickle-cell disease can be treated in mice.[66] The mice which have essentially the same defect that causes human cases used a viral vector to induce production of fetal hemoglobin (HbF), which normally ceases to be produced shortly after birth. In humans, the use of hydroxyurea to stimulate the production of HbF temporarily alleviates sickle cell symptoms. The researchers demonstrated this treatment to be a more permanent means to increase therapeutic HbF production.[67]

A new gene therapy approach repaired errors in messenger RNA derived from defective genes. This technique has the potential to treat thalassaemia, cystic fibrosis and some cancers.[68]

Researchers created liposomes 25 nanometers across that can carry therapeutic DNA through pores in the nuclear membrane.[69]

In 2003 a research team inserted genes into the brain for the first time. They used liposomes coated in a polymer called polyethylene glycol, which unlike viral vectors, are small enough to cross the bloodbrain barrier.[70]

Short pieces of double-stranded RNA (short, interfering RNAs or siRNAs) are used by cells to degrade RNA of a particular sequence. If a siRNA is designed to match the RNA copied from a faulty gene, then the abnormal protein product of that gene will not be produced.[71]

Gendicine is a cancer gene therapy that delivers the tumor suppressor gene p53 using an engineered adenovirus. In 2003, it was approved in China for the treatment of head and neck squamous cell carcinoma.[25]

In March researchers announced the successful use of gene therapy to treat two adult patients for X-linked chronic granulomatous disease, a disease which affects myeloid cells and damages the immune system. The study is the first to show that gene therapy can treat the myeloid system.[72]

In May a team reported a way to prevent the immune system from rejecting a newly delivered gene.[73] Similar to organ transplantation, gene therapy has been plagued by this problem. The immune system normally recognizes the new gene as foreign and rejects the cells carrying it. The research utilized a newly uncovered network of genes regulated by molecules known as microRNAs. This natural function selectively obscured their therapeutic gene in immune system cells and protected it from discovery. Mice infected with the gene containing an immune-cell microRNA target sequence did not reject the gene.

In August scientists successfully treated metastatic melanoma in two patients using killer T cells genetically retargeted to attack the cancer cells.[74]

In November researchers reported on the use of VRX496, a gene-based immunotherapy for the treatment of HIV that uses a lentiviral vector to deliver an antisense gene against the HIV envelope. In a phase I clinical trial, five subjects with chronic HIV infection who had failed to respond to at least two antiretroviral regimens were treated. A single intravenous infusion of autologous CD4 T cells genetically modified with VRX496 was well tolerated. All patients had stable or decreased viral load; four of the five patients had stable or increased CD4 T cell counts. All five patients had stable or increased immune response to HIV antigens and other pathogens. This was the first evaluation of a lentiviral vector administered in a US human clinical trial.[75][76]

In May researchers announced the first gene therapy trial for inherited retinal disease. The first operation was carried out on a 23-year-old British male, Robert Johnson, in early 2007.[77]

Leber’s congenital amaurosis is an inherited blinding disease caused by mutations in the RPE65 gene. The results of a small clinical trial in children were published in April.[11] Delivery of recombinant adeno-associated virus (AAV) carrying RPE65 yielded positive results. In May two more groups reported positive results in independent clinical trials using gene therapy to treat the condition. In all three clinical trials, patients recovered functional vision without apparent side-effects.[11][12][13][14]

In September researchers were able to give trichromatic vision to squirrel monkeys.[78] In November 2009, researchers halted a fatal genetic disorder called adrenoleukodystrophy in two children using a lentivirus vector to deliver a functioning version of ABCD1, the gene that is mutated in the disorder.[79]

An April paper reported that gene therapy addressed achromatopsia (color blindness) in dogs by targeting cone photoreceptors. Cone function and day vision were restored for at least 33 months in two young specimens. The therapy was less efficient for older dogs.[80]

In September it was announced that an 18-year-old male patient in France with beta-thalassemia major had been successfully treated.[81] Beta-thalassemia major is an inherited blood disease in which beta haemoglobin is missing and patients are dependent on regular lifelong blood transfusions.[82] The technique used a lentiviral vector to transduce the human -globin gene into purified blood and marrow cells obtained from the patient in June 2007.[83] The patient’s haemoglobin levels were stable at 9 to 10 g/dL. About a third of the hemoglobin contained the form introduced by the viral vector and blood transfusions were not needed.[83][84] Further clinical trials were planned.[85] Bone marrow transplants are the only cure for thalassemia, but 75% of patients do not find a matching donor.[84]

Cancer immunogene therapy using modified antigene, antisense/triple helix approach was introduced in South America in 2010/11 in La Sabana University, Bogota (Ethical Committee 14 December 2010, no P-004-10). Considering the ethical aspect of gene diagnostic and gene therapy targeting IGF-I, the IGF-I expressing tumors i.e. lung and epidermis cancers were treated (Trojan et al. 2016).[86][87]

In 2007 and 2008, a man (Timothy Ray Brown) was cured of HIV by repeated hematopoietic stem cell transplantation (see also allogeneic stem cell transplantation, allogeneic bone marrow transplantation, allotransplantation) with double-delta-32 mutation which disables the CCR5 receptor. This cure was accepted by the medical community in 2011.[88] It required complete ablation of existing bone marrow, which is very debilitating.

In August two of three subjects of a pilot study were confirmed to have been cured from chronic lymphocytic leukemia (CLL). The therapy used genetically modified T cells to attack cells that expressed the CD19 protein to fight the disease.[20] In 2013, the researchers announced that 26 of 59 patients had achieved complete remission and the original patient had remained tumor-free.[89]

Human HGF plasmid DNA therapy of cardiomyocytes is being examined as a potential treatment for coronary artery disease as well as treatment for the damage that occurs to the heart after myocardial infarction.[90][91]

In 2011 Neovasculgen was registered in Russia as the first-in-class gene-therapy drug for treatment of peripheral artery disease, including critical limb ischemia; it delivers the gene encoding for VEGF.[92][26] Neovasculogen is a plasmid encoding the CMV promoter and the 165 amino acid form of VEGF.[93][94]

The FDA approved Phase 1 clinical trials on thalassemia major patients in the US for 10 participants in July.[95] The study was expected to continue until 2015.[85]

In July 2012, the European Medicines Agency recommended approval of a gene therapy treatment for the first time in either Europe or the United States. The treatment used Alipogene tiparvovec (Glybera) to compensate for lipoprotein lipase deficiency, which can cause severe pancreatitis.[96] The recommendation was endorsed by the European Commission in November 2012[10][27][97][98] and commercial rollout began in late 2014.[99] Alipogene tiparvovec was expected to cost around $1.6 million per treatment in 2012,[100] revised to $1 million in 2015,[101] making it the most expensive medicine in the world at the time.[102] As of 2016[update], only one person had been treated with drug.[103]

In December 2012, it was reported that 10 of 13 patients with multiple myeloma were in remission “or very close to it” three months after being injected with a treatment involving genetically engineered T cells to target proteins NY-ESO-1 and LAGE-1, which exist only on cancerous myeloma cells.[22]

In March researchers reported that three of five adult subjects who had acute lymphocytic leukemia (ALL) had been in remission for five months to two years after being treated with genetically modified T cells which attacked cells with CD19 genes on their surface, i.e. all B-cells, cancerous or not. The researchers believed that the patients’ immune systems would make normal T-cells and B-cells after a couple of months. They were also given bone marrow. One patient relapsed and died and one died of a blood clot unrelated to the disease.[21]

Following encouraging Phase 1 trials, in April, researchers announced they were starting Phase 2 clinical trials (called CUPID2 and SERCA-LVAD) on 250 patients[104] at several hospitals to combat heart disease. The therapy was designed to increase the levels of SERCA2, a protein in heart muscles, improving muscle function.[105] The FDA granted this a Breakthrough Therapy Designation to accelerate the trial and approval process.[106] In 2016 it was reported that no improvement was found from the CUPID 2 trial.[107]

In July researchers reported promising results for six children with two severe hereditary diseases had been treated with a partially deactivated lentivirus to replace a faulty gene and after 732 months. Three of the children had metachromatic leukodystrophy, which causes children to lose cognitive and motor skills.[108] The other children had Wiskott-Aldrich syndrome, which leaves them to open to infection, autoimmune diseases, and cancer.[109] Follow up trials with gene therapy on another six children with Wiskott-Aldrich syndrome were also reported as promising.[110][111]

In October researchers reported that two children born with adenosine deaminase severe combined immunodeficiency disease (ADA-SCID) had been treated with genetically engineered stem cells 18 months previously and that their immune systems were showing signs of full recovery. Another three children were making progress.[18] In 2014 a further 18 children with ADA-SCID were cured by gene therapy.[112] ADA-SCID children have no functioning immune system and are sometimes known as “bubble children.”[18]

Also in October researchers reported that they had treated six hemophilia sufferers in early 2011 using an adeno-associated virus. Over two years later all six were producing clotting factor.[18][113]

In January researchers reported that six choroideremia patients had been treated with adeno-associated virus with a copy of REP1. Over a six-month to two-year period all had improved their sight.[114][115] By 2016, 32 patients had been treated with positive results and researchers were hopeful the treatment would be long-lasting.[15] Choroideremia is an inherited genetic eye disease with no approved treatment, leading to loss of sight.

In March researchers reported that 12 HIV patients had been treated since 2009 in a trial with a genetically engineered virus with a rare mutation (CCR5 deficiency) known to protect against HIV with promising results.[116][117]

Clinical trials of gene therapy for sickle cell disease were started in 2014.[118][119] There is a need for high quality randomised controlled trials assessing the risks and benefits involved with gene therapy for people with sickle cell disease.[120]

In February LentiGlobin BB305, a gene therapy treatment undergoing clinical trials for treatment of beta thalassemia gained FDA “breakthrough” status after several patients were able to forgo the frequent blood transfusions usually required to treat the disease.[121]

In March researchers delivered a recombinant gene encoding a broadly neutralizing antibody into monkeys infected with simian HIV; the monkeys’ cells produced the antibody, which cleared them of HIV. The technique is named immunoprophylaxis by gene transfer (IGT). Animal tests for antibodies to ebola, malaria, influenza, and hepatitis were underway.[122][123]

In March, scientists, including an inventor of CRISPR, Jennifer Doudna, urged a worldwide moratorium on germline gene therapy, writing “scientists should avoid even attempting, in lax jurisdictions, germline genome modification for clinical application in humans” until the full implications “are discussed among scientific and governmental organizations”.[124][125][126][127]

In October, researchers announced that they had treated a baby girl, Layla Richards, with an experimental treatment using donor T-cells genetically engineered using TALEN to attack cancer cells. One year after the treatment she was still free of her cancer (a highly aggressive form of acute lymphoblastic leukaemia [ALL]).[128] Children with highly aggressive ALL normally have a very poor prognosis and Layla’s disease had been regarded as terminal before the treatment.[129]

In December, scientists of major world academies called for a moratorium on inheritable human genome edits, including those related to CRISPR-Cas9 technologies[130] but that basic research including embryo gene editing should continue.[131]

In April the Committee for Medicinal Products for Human Use of the European Medicines Agency endorsed a gene therapy treatment called Strimvelis[132][133] and the European Commission approved it in June.[134] This treats children born with adenosine deaminase deficiency and who have no functioning immune system. This was the second gene therapy treatment to be approved in Europe.[135]

In October, Chinese scientists reported they had started a trial to genetically modify T-cells from 10 adult patients with lung cancer and reinject the modified T-cells back into their bodies to attack the cancer cells. The T-cells had the PD-1 protein (which stops or slows the immune response) removed using CRISPR-Cas9.[136][137]

A 2016 Cochrane systematic review looking at data from four trials on topical cystic fibrosis transmembrane conductance regulator (CFTR) gene therapy does not support its clinical use as a mist inhaled into the lungs to treat cystic fibrosis patients with lung infections. One of the four trials did find weak evidence that liposome-based CFTR gene transfer therapy may lead to a small respiratory improvement for people with CF. This weak evidence is not enough to make a clinical recommendation for routine CFTR gene therapy.[138]

In February Kite Pharma announced results from a clinical trial of CAR-T cells in around a hundred people with advanced Non-Hodgkin lymphoma.[139]

In March, French scientists reported on clinical research of gene therapy to treat sickle-cell disease.[140]

In August, the FDA approved tisagenlecleucel for acute lymphoblastic leukemia.[141] Tisagenlecleucel is an adoptive cell transfer therapy for B-cell acute lymphoblastic leukemia; T cells from a person with cancer are removed, genetically engineered to make a specific T-cell receptor (a chimeric T cell receptor, or “CAR-T”) that reacts to the cancer, and are administered back to the person. The T cells are engineered to target a protein called CD19 that is common on B cells. This is the first form of gene therapy to be approved in the United States. In October, a similar therapy called axicabtagene ciloleucel was approved for non-Hodgkin lymphoma.[142]

In December the results of using an adeno-associated virus with blood clotting factor VIII to treat nine haemophilia A patients were published. Six of the seven patients on the high dose regime increased the level of the blood clotting VIII to normal levels. The low and medium dose regimes had no effect on the patient’s blood clotting levels.[143][144]

In December, the FDA approved Luxturna, the first in vivo gene therapy, for the treatment of blindness due to Leber’s congenital amaurosis.[145] The price of this treatment was 850,000 US dollars for both eyes.[146][147]

Speculated uses for gene therapy include:

Athletes might adopt gene therapy technologies to improve their performance.[148] Gene doping is not known to occur, but multiple gene therapies may have such effects. Kayser et al. argue that gene doping could level the playing field if all athletes receive equal access. Critics claim that any therapeutic intervention for non-therapeutic/enhancement purposes compromises the ethical foundations of medicine and sports.[149]

Genetic engineering could be used to cure diseases, but also to change physical appearance, metabolism, and even improve physical capabilities and mental faculties such as memory and intelligence. Ethical claims about germline engineering include beliefs that every fetus has a right to remain genetically unmodified, that parents hold the right to genetically modify their offspring, and that every child has the right to be born free of preventable diseases.[150][151][152] For parents, genetic engineering could be seen as another child enhancement technique to add to diet, exercise, education, training, cosmetics, and plastic surgery.[153][154] Another theorist claims that moral concerns limit but do not prohibit germline engineering.[155]

Possible regulatory schemes include a complete ban, provision to everyone, or professional self-regulation. The American Medical Associations Council on Ethical and Judicial Affairs stated that “genetic interventions to enhance traits should be considered permissible only in severely restricted situations: (1) clear and meaningful benefits to the fetus or child; (2) no trade-off with other characteristics or traits; and (3) equal access to the genetic technology, irrespective of income or other socioeconomic characteristics.”[156]

As early in the history of biotechnology as 1990, there have been scientists opposed to attempts to modify the human germline using these new tools,[157] and such concerns have continued as technology progressed.[158][159] With the advent of new techniques like CRISPR, in March 2015 a group of scientists urged a worldwide moratorium on clinical use of gene editing technologies to edit the human genome in a way that can be inherited.[124][125][126][127] In April 2015, researchers sparked controversy when they reported results of basic research to edit the DNA of non-viable human embryos using CRISPR.[160][161] A committee of the American National Academy of Sciences and National Academy of Medicine gave qualified support to human genome editing in 2017[162][163] once answers have been found to safety and efficiency problems “but only for serious conditions under stringent oversight.”[164]

Regulations covering genetic modification are part of general guidelines about human-involved biomedical research. There are no international treaties which are legally binding in this area, but there are recommendations for national laws from various bodies.

The Helsinki Declaration (Ethical Principles for Medical Research Involving Human Subjects) was amended by the World Medical Association’s General Assembly in 2008. This document provides principles physicians and researchers must consider when involving humans as research subjects. The Statement on Gene Therapy Research initiated by the Human Genome Organization (HUGO) in 2001 provides a legal baseline for all countries. HUGOs document emphasizes human freedom and adherence to human rights, and offers recommendations for somatic gene therapy, including the importance of recognizing public concerns about such research.[165]

No federal legislation lays out protocols or restrictions about human genetic engineering. This subject is governed by overlapping regulations from local and federal agencies, including the Department of Health and Human Services, the FDA and NIH’s Recombinant DNA Advisory Committee. Researchers seeking federal funds for an investigational new drug application, (commonly the case for somatic human genetic engineering,) must obey international and federal guidelines for the protection of human subjects.[166]

NIH serves as the main gene therapy regulator for federally funded research. Privately funded research is advised to follow these regulations. NIH provides funding for research that develops or enhances genetic engineering techniques and to evaluate the ethics and quality in current research. The NIH maintains a mandatory registry of human genetic engineering research protocols that includes all federally funded projects.

An NIH advisory committee published a set of guidelines on gene manipulation.[167] The guidelines discuss lab safety as well as human test subjects and various experimental types that involve genetic changes. Several sections specifically pertain to human genetic engineering, including Section III-C-1. This section describes required review processes and other aspects when seeking approval to begin clinical research involving genetic transfer into a human patient.[168] The protocol for a gene therapy clinical trial must be approved by the NIH’s Recombinant DNA Advisory Committee prior to any clinical trial beginning; this is different from any other kind of clinical trial.[167]

As with other kinds of drugs, the FDA regulates the quality and safety of gene therapy products and supervises how these products are used clinically. Therapeutic alteration of the human genome falls under the same regulatory requirements as any other medical treatment. Research involving human subjects, such as clinical trials, must be reviewed and approved by the FDA and an Institutional Review Board.[169][170]

Gene therapy is the basis for the plotline of the film I Am Legend[171] and the TV show Will Gene Therapy Change the Human Race?.[172] In 1994, gene therapy was a plot element in The Erlenmeyer Flask, The X-Files’ first-season finale. It is also used in Stargate as a means of allowing humans to use Ancient technology.[173]

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Gene therapy – Wikipedia

Genetic Engineering Will Change Everything Forever …

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SOURCES AND FURTHER READING:

The best book we read about the topic: GMO Sapiens

https://goo.gl/NxFmk8

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Good Overview by Wired:http://bit.ly/1DuM4zq

timeline of computer development:http://bit.ly/1VtiJ0N

Selective breeding: http://bit.ly/29GaPVS

DNA:http://bit.ly/1rQs8Yk

Radiation research:http://bit.ly/2ad6wT1

inserting DNA snippets into organisms:http://bit.ly/2apyqbj

First genetically modified animal:http://bit.ly/2abkfYO

First GM patent:http://bit.ly/2a5cCox

chemicals produced by GMOs:http://bit.ly/29UvTbhhttp://bit.ly/2abeHwUhttp://bit.ly/2a86sBy

Flavr Savr Tomato:http://bit.ly/29YPVwN

First Human Engineering:http://bit.ly/29ZTfsf

glowing fish:http://bit.ly/29UwuJU

CRISPR:http://go.nature.com/24Nhykm

HIV cut from cells and rats with CRISPR:http://go.nature.com/1RwR1xIhttp://ti.me/1TlADSi

first human CRISPR trials fighting cancer:http://go.nature.com/28PW40r

first human CRISPR trial approved by Chinese for August 2016:http://go.nature.com/29RYNnK

genetic diseases:http://go.nature.com/2a8f7ny

pregnancies with Down Syndrome terminated:http://bit.ly/2acVyvg( 1999 European study)

CRISPR and aging:http://bit.ly/2a3NYAVhttp://bit.ly/SuomTyhttp://go.nature.com/29WpDj1http://ti.me/1R7Vus9

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Genetic Engineering Will Change Everything Forever …

Cryptocurrency News: Bitcoin ETFs, Andreessen Horowitz, and Contradictions in Crypto

Cryptocurrency News
This was a bloody week for cryptocurrencies. Everything was covered in red, from Ethereum (ETH) on down to the Basic Attention Token (BAT).

Some investors claim it was inevitable. Others say that price manipulation is to blame.

We think the answers are more complicated than either side has to offer, because our research reveals deep contradictions between the price of cryptos and the underlying development of blockchain projects.

For instance, a leading venture capital (VC) firm launched a $300.0-million crypto investment fund, yet liquidity continues to dry up in crypto markets.

Another example is the U.S. Securities and Exchange Commission’s.

The post Cryptocurrency News: Bitcoin ETFs, Andreessen Horowitz, and Contradictions in Crypto appeared first on Profit Confidential.

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Cryptocurrency News: Bitcoin ETFs, Andreessen Horowitz, and Contradictions in Crypto