3 stem cell procedures recognized in PH FDA

The Food and Drug Administration (FDA) yesterday reiterated that stem cell procedures in the Philippines are allowed only for three specific procedures while others remain unrecognized by the agency and are therefore illegal.

In an advisory posted on its website, Dr. Kenneth Hartigan-Go, FDA acting director, emphasized that only the following uses of stem cell therapy are recognized by the FDA Hematopoietic Transplantation (involving the blood cells to treat disorders of the blood and immune systems), Corneal Resurfacing with limbal stem cells (to treat the transparent, front part of the eye), and skin regeneration (for burns) with epidermal stem cells. All hospitals and health facilities are likewise warned that Republic Act 9711 or the FDA Act, otherwise prohibits the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is unregistered. The use of Human cells, Tissues, and Cellular and tissue-based products (HCT/Ps) without the authorization or permission by the FDA is considered illegal in the country, Go said.

In August 2013, the FDA issued a circular asking hospitals and other facilities offering stem cell procedures to register for accreditation. However, as of May 2, the FDA said not one stem cell or HCT product that applied for registration has been registered by the FDA for compassionate or clinical trial use or for general use.

What we are doing now is we are strengthening quality assurancethey must have scientific proof. But there is no one who is applying for compassionate use because if we ask them about ethical clearance, they have no ethical review system, the FDA chief added.

Go warned all hospitals and health facilities to stop manufacturing or selling unregistered products.

The warning also covers unlicensed practitioners from other countries and tourists who visit the country for leisure or medical needs. (Jenny F. Manongdo)

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3 stem cell procedures recognized in PH FDA

FDA: No way spas can do stem-cell therapy

Health authorities on Saturday reissued warnings against health facilities and medical practitioners offering stem-cell therapies or related products, which promise to cure a range of diseases, arrest the aging process or even increase libido.

In an advisory, the Food and Drug Administration stressed that to date not one stem cell or human cells, tissues, and cellular and tissue-based products (HCT/Ps) that applied for registration has been registered by the FDA for compassionate or clinical trial use or for general use.

The use of HCT/Ps without the authorization or permission by the FDA is considered illegal, it said. The agency warned hospitals and health facilities of the provisions of the FDA Act of 2009, which prohibits the manufacture, use, advertisement or sponsorship of unregistered health products.

This warning extends to all unlicensed practitioners from other countries and to tourists who visit the Philippines for leisure and medical needs.

According to FDA acting director general Kenneth Hartigan Go, the FDA recognizes only hematopoietic (pertaining to the formation and development of blood cells) stem-cell transplantation, corneal resurfacing with limbal stem cells and skin regeneration with epidermal stem cells as generally accepted standards of healthcare procedures.

If health institutions are doing these three procedures, they can continue because those are allowed, Go said.

But the efficacy of the use of stem cells for the treatment of other diseases, such as diabetes, cancer and autism, among others, have yet to be proven, he said.

Go noted that while many spa centers and salons are advertising stem-cell therapy treatment and products, none of them have secured the FDAs approval. As of now, we have not accredited any health facility offering stem-cell therapy yet.

Applicants with deficiencies

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FDA: No way spas can do stem-cell therapy

Spirituality | Astrology | Other Realities | RE incarnation | Living your highest joy! – Video


Spirituality | Astrology | Other Realities | RE incarnation | Living your highest joy!
CLICK HERE http://www.simonvorster.com/ This channel is created for the teaching of a spiritual art of Astrology. These teachings are to educate everyone on the importance and effect of astrology...

By: Simon Vorster

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Spirituality | Astrology | Other Realities | RE incarnation | Living your highest joy! - Video

Spirituality | Astrology | A Story Of Re-Alignment | Uranus Aries | Virgo Pisces | Cardinal Cross – Video


Spirituality | Astrology | A Story Of Re-Alignment | Uranus Aries | Virgo Pisces | Cardinal Cross
CLICK HERE http://www.simonvorster.com/ This channel is created for the teaching of a spiritual art of Astrology. These teachings are to educate everyone on the importance and effect of astrology...

By: Simon Vorster

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Spirituality | Astrology | A Story Of Re-Alignment | Uranus Aries | Virgo Pisces | Cardinal Cross - Video

Scientists Working Hard To Prevent Microbial Invasion On Other Worlds

Image Caption: The European Technology Exposure Facility (EuTEF) attached to the Columbus module of the International Space Station during orbital flight. Credit: DLR, Institute of Aerospace Medicine/Dr. Gerda Horneck

redOrbit Staff & Wire Reports Your Universe Online

In order to avoid potential microbial contamination while searching for signs of microbial life on other planets, the authors of three recently-published studies have used research from the International Space Station to analyze the risks of accidentally transporting organisms from Earth into outer space.

Currently, spacecraft that land on Mars or other potentially habitable worlds have to meet strict requirements for the maximum level of microbial life, also known as bioburden. These permissible levels have been based on studies of how various life forms can survive traveling aboard a spacecraft or landing vehicle.

If you are able to reduce the numbers to acceptable levels, a proxy for cleanliness, the assumption is that the life forms will not survive under harsh space conditions, Kasthuri J. Venkateswaran, a co-author on all three studies and a researcher with the Biotechnology and Planetary Protection Group at NASAs Jet Propulsion Laboratory, said in a statement Friday.

However, recent studies have indicated that such an assumption might not be valid, since some types of microbial live have proven to be hardier than previously believed and others could develop a variety of protective mechanisms in order to handle the rigors of space travel. To that end, each of the three new studies set out to investigate different types of organisms to find out how they might react to an interplanetary voyage.

The researchers are most concerned with spore-forming bacteria, since they are able to survive following some types of sterilization procedures and could be most capable of surviving after leaving Earth. In particular, Bacillus pumilus SAFR-032 spores have demonstrated high resistance to the techniques typically used to clear spacecraft, including ultraviolet radiation and treatment with peroxide, the researchers said.

They exposed Bacillus pumilus SAFR-032 to simulated conditions on Mars an environment capable of killing many other types of bacteria in just 30 seconds and found that it was able to remain alive for 30 minutes. In another experiment, they exposed the spores to 18 months on the European Technology Exposure Facility (EuTEF) external testing ground, and found that some of them were able to survive for the entire duration.

According to NASA, the surviving Bacillus pumilus SAFR-032 spores had higher concentrations of proteins associated with UV radiation resistance and, in fact, showed elevated UV resistance when revived and re-exposed on Earth. The findings also provide insight into how robust microbial communities are able to survive in extremely hostile regions on Earth and how these microbes are affected by radiation.

A second study involved drying out spores of Bacillus pumilus SAFR-032 and another spore-forming microbe, Bacillus subtilis 168, on pieces of spacecraft-quality aluminum. They were then subjected to 18 months of the vacuum of space, as well as cosmic and extraterrestrial solar radiation and temperature changes, on EuTEF. The samples were then subjected to a simulated Martian atmosphere using the external testing facility.

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Scientists Working Hard To Prevent Microbial Invasion On Other Worlds

Red Bluff City Council to take on budget proposal, shelter agreement

By Andre Byik

abyik@redbluffdailynews.com @andrebyik on Twitter

Red Bluff >> The Red Bluff City Council on Tuesday will consider adopting a 2014-15 fiscal year budget that for the second consecutive year would have the city spending more than it takes in.

The budget still has its share of cuts, thought.

In the proposed budget, the yearly funding of the Red Bluff-Tehama County Chamber of Commerce would be sliced in half, and police and fire department spending would be reduced 2.5 percent.

In its report to the full council the city's budget committee, made up of council members Wayne Brown and Rob Schmid, said those tough budget cuts are necessary to achieve a year-end cash balance goal of $500,000.

The city's budget committee estimates a general fund balance of $648,062 as it heads into in the next fiscal year, according to a staff document. The proposed budget ends with an estimated general fund balance of $516,801, a decrease of $131,261.

City Finance Director Sandy Ryan has previously said the city needs to maintain a fund balance of around $1.3 million, which would be two months of general fund spending. It is city policy to reserve 15 percent of general fund expenditures, which would be $1.2 million, for uncertainties and contingencies.

The increase in city costs is attributed to pay raises and benefit cost increases required by agreements made with the city's union employees that were conditionally tied to any increases the city saw in sales tax revenue.

A 4.5 percent increase in police, fire and miscellaneous wages is included in the proposed budget because of existing agreements. The increase comes at a general fund cost of $134,000.

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Red Bluff City Council to take on budget proposal, shelter agreement

NASA seeks help to save Earth from killer asteroids

With nothing less at stake than the future of planet Earth, NASA has decided to crowdsource ideas to detect and track asteroids that have the potential to wipe out life as we know it.

After a previously undetected, 65-foot-wide asteroid exploded over Russia in February 2013, unleashing the force of 500,000 tons of TNT, NASA launched a series of contests for smart folks around the globe to come up with ways to keep an eye on asteroids that could threaten Earth.

Currently, NASA estimates that only 1 percent of the millions of asteroids hurtling around our solar system have been found.

So NASA calls the series of contests that make up the Asteroid Grand Challenge "a broad call to action" to defend Earth against any number of asteroids that could be bearing down on us right this instant.

"Good ideas can come from anywhere," said Ben Burress, staff astronomer at Oakland's Chabot Space & Science Center, which is not affiliated with NASA's Asteroid Grand Challenge. "There are millions of asteroids we don't know about, so the idea of more information really is better. Are we going to be hit? Yes. The question is, when and by how big of an asteroid?"

In a video announcing the series of contests, a NASA narrator says, "Asteroid hunting is an activity everyone can get involved with, whether it's writing computer code, building hardware, making observations through a telescope. Survival is its own reward. It's up to each of us to protect our planet from asteroids."

And in a throw down to all citizens of Earth, the narrator says, "The dinosaurs would have cared if they knew about this problem."

With NASA out of the business of launching humans into space -- and asteroid killer and action star Bruce Willis on the bench --"Earth's defense," as NASA calls it, is left in the hands of mere mortals.

NASA first invited what it calls "citizen scientists" to join the search for killer asteroids in March at the South by Southwest festival in Austin, Texas, during a session titled, "Are We Smarter than the Dinosaurs?"

On Friday, NASA ended the third contest of its competition to create an algorithm to detect hidden asteroids. No fewer than 422 people from 63 countries -- from Argentina to Zimbabwe -- submitted algorithmic solutions.

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NASA's Orbiting Carbon Observatory-2 Satellite Arrives At Launch Site

May 2, 2014

Image Caption: A truck convoy carrying NASA's Orbiting Carbon Observatory-2 spacecraft arrives at California's Vandenberg Air Force Base April 30. The observatory will undergo final tests and then be integrated atop a United Launch Alliance Delta II rocket in preparation for a planned July 1 launch. Credit: NASA/JPL-Caltech

NASAs Jet Propulsion Laboratory

A NASA spacecraft designed to make precise measurements of carbon dioxide in Earths atmosphere is at Vandenberg Air Force Base, Calif., to begin final preparations for launch.

The Orbiting Carbon Observatory-2 arrived Wednesday at its launch site on Californias central coast after traveling from Orbital Sciences Corp.s Satellite Manufacturing Facility in Gilbert, Ariz. The spacecraft now will undergo final tests and then be integrated on top of a United Launch Alliance Delta II rocket in preparation for a planned July 1 launch.

The observatory is NASAs first satellite mission dedicated to studying carbon dioxide, a critical component of Earths carbon cycle that is the leading human-produced greenhouse gas driving changes in Earths climate. It replaces a nearly identical spacecraft lost due to a rocket launch mishap in February 2009.

OCO-2 will provide a new tool for understanding both the sources of carbon dioxide emissions and the natural processes that remove carbon dioxide from the atmosphere, and how they are changing over time. Since the start of the Industrial Revolution more than 200 years ago, the burning of fossil fuels, as well as other human activities, have led to an unprecedented buildup in this greenhouse gas, which is now at its highest level in at least 800,000 years. Human activities have increased the level of carbon dioxide by more than 25 percent in just the past half century.

Greenhouse gases, such as carbon dioxide, trap the suns heat within Earths atmosphere, warming it and keeping it at habitable temperatures. However, scientists have concluded that increases in carbon dioxide resulting from human activities have thrown Earths natural carbon cycle off balance, increasing global temperatures and changing the planets climate.

While scientists understand carbon dioxide emissions resulting from burning fossil fuels and can estimate their quantity quite accurately, their understanding of carbon dioxide from other human-produced and natural sources is relatively less quantified. Atmospheric measurements collected at ground stations indicate less than half of the carbon dioxide humans emit into the atmosphere stays there. The rest is believed to be absorbed by the ocean and plants on land.

But the locations and identity of the natural sinks absorbing this carbon dioxide currently are not well understood. OCO-2 will help solve this critical scientific puzzle. Quantifying how the natural processes are helping remove carbon from the atmosphere will help scientists construct better models to predict how much carbon dioxide these sinks will be able to absorb in the future.

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NASA's Orbiting Carbon Observatory-2 Satellite Arrives At Launch Site