Baby Boomers turn to stem cells for help with painful joints – The San Diego Union-Tribune

For pain doctor Mark Wallace, arthritis meant his hobby of competitive swimming was becoming too painful.

Every stroke was like an ice pick in my shoulder, said Wallace, chief of the division of pain medicine at UC San Diego. Cortisone shots relieved the pain for about a month, and then it would return.

For philanthropist Denny Sanford, even walking was too painful. He sought relief for his arthritis with a right knee replacement, but that didnt work well. So to treat his other knee, he looked for an alternative.

Wallace and Sanford said they found that relief with stem cells; Wallace at UC San Diego using cells from his bone marrow, and Sanford at a clinic in Germany using cells from his fat tissue. Their cases particularly Wallaces illustrate how the use of stem cells to relieve joint pain is becoming an accepted part of orthopedic medicine.

With millions of baby boomers experiencing the miseries of arthritis, the need is great and growing. However, the zoo of stem cell treatments is confusing. Outside of legitimate clinical trials, outright quackery proliferates. And legitimate or not, insurance generally doesnt cover these treatments, which can cost several thousands of dollars, or even tens of thousands of dollars.

Those looking for legitimate stem cell treatments face bewildering choices about where to go and which of the many kinds of stem cells are best for their condition.

Arthritis sufferers need to be realistic about what stem cells can do, said Dr. William Bugbee, an orthopedic surgeon who practices at Scripps Health. They may experience a relief in pain, but again they might not. And patients who expect stem cells to regenerate their deteriorated joints will be disappointed.

There's a whole gamut of things that fall under regenerative medicine, Bugbee said. But there's really nothing scientifically proven to regenerate tissue, particularly in arthritic joints. So the term regenerative medicine is sexy, but it doesn't really describe what we can do clinically.

That said, pain relief in itself is a major achievement in those with arthritis.

There is a huge business to manage arthritic pain in patients that don't need a new knee or knee replacement, Bugbee said. And we have very few effective long-lasting treatments and certainly no treatments that slow the progression of the disease. So there's a huge need. So these treatments like stem cells are filling a void for people who want to get symptom relief.

Bugbee said he cautions patients keep their expectations in check.

I would say this might provide you some symptom relief, you might get a few months or six months or a year of relief, but you might not. And I don't know that it's better than giving you a cortisone shot, Bugbee said. But some people respond. And so it's worth it if they've tried other options and they don't really want to have surgery yet.

Scores of therapies derived from stem cells are in clinical trials in the United States. While some have shown promising results in experimental testing, none have yet been approved by the U.S. Food and Drug Administration.

However, doctors have the authority to perform certain kinds of stem cell treatments on their own. These involve autologous cells, taken from the patient, and minimally manipulated. Doctors separate the desired cells, such as by spinning them in a centrifuge, and then re-injecting these same cells at the point of treatment.

But the precise definition of what doctors can and cant do is unclear, leaving a gray area where doctors act on their own. In some cases, the outcome is tragic. Three people with macular degeneration were left blind after being treated at a Florida stem cell clinic with their autologous cells. Moreover, the trials were registered with a web site called clinicaltrials.gov, a service of the National Institutes of Health. The NIH doesnt fully vet these trials for scientific soundness.

The orthopedic use of stem cells to relieve joint pain falls on the legitimate side of this gray area, said Bugbee and Paul Knoepfler, a stem cell researcher at UC Davis.

Knoepfler said a reputable academic medical center such as UC San Diego is a good place to look for legitimate treatment. Also, patients should consider what kind of stem cells are to be used, and whether its reasonable to expect they have the power to treat the condition. This is a principle called homologous use, he said.

Using stem cells derived from bone marrow to treat arthritis fits the homologous use principle, Knoepfler said. But injecting those cells into the brain to treat autism would not, he said.

In addition to his aching left shoulder, UC San Diego pain physician Wallace suffered from a strained medial collateral ligament on the inside of his right knee that had never healed. He sought relief from another pain doctor at the university, Jeffrey Chen.

When Chen told colleagues he was taking volunteers for a stem cell treatment, using a centrifuge he was testing, Wallace jumped at the chance. Bone marrow was extracted from his left hip, processed through the centrifuge, and the separated cells injected into the painful joint and the knee ligament.

Some inflammation resulted, and the pain actually got somewhat worse for a week, Wallace said. The cells initially cause inflammation, hence the pain.

After a week it went back to baseline, Wallace said. And then each week was getting better and better and better. It took about four weeks and then I was doing breast stroke kicks and I had very little pain in my shoulder. Now it's been over two years.

Wallaces positive response couldnt have be predicted, Chen said. Some patients get no relief, some do.

To improve results, doctors are experimenting with different approaches, different kinds of centrifuges, different combinations of cells, sometimes including non-stem cells that help the pain relief process.

People are getting relief, Chen said. But you have to make sure it's consistent and that the mechanism is understood.

Inflammation is a necessary part of the healing cascade, Chen said. Steroids suppress inflammation, providing temporary relief at the expense of slowing down long-term healing.

Were trying to shorten that healing cascade, Chen said. We actually want some inflammation in there so it actually heals. This is one of the ways that potentially could do that for us.

Denny Sanford, the philanthropist who got stem cell therapy for his left knee, likewise said that it worked for him, actually regenerating some cartilage.

Sanford went to a clinic in Munich, Germany operated by Sanford Health, one of the beneficiaries of his philanthropy. As in Wallaces case, the cells were also autologous, but from a different source, Sanfords adipose or fat tissue.

Sanford spoke about the results at a recent conference in San Diego on the use of stem cells for orthopedic purposes.

I had a full mechanical knee put in on the right side, and it was absolutely, horribly painful, Sanford said. I didnt want to go through that again.

Besides the ongoing pain, the mechanical knee makes an annoying clicking sound when walking, Sanford said. The procedure in Germany was simple by comparison, he said, and recovery time and results were superior.

Three months recovery on the mechanical knee, three weeks on the stem cell knee, Sanford said. Today, the pain is virtually nonexistent in the stem cell knee versus the mechanical knee. It works beautifully. And its been year and a half.

Sanford said in an interview that Germanys regulations allow better access to these therapies than in the United States, and noted athletes such as golfer Jack Nicklaus have gone there.

One of the things that made procedure attractive was the low risk of using the stem cells, Sanford said.

They may not do anything, but in my case they have, he said.

Dr. Darryl DLima is director of Orthopedic Research at Scripps Healths Shiley Center for Orthopaedic Research and Education. He says clinical trials vary in scientific validity, and patients should keep those differences in mind.

The most valid studies randomly assign patients to either receive the experimental therapy or not, so differences among the two patient group and control group are likely related to the treatment, DLima said.

In the stem cell world, these studies are relatively few.

I would say 80 to 90 percent of so-called clinical studies are lower-level studies classified as cohort studies, DLima said.

These studies arent approved by the FDA, but are authorized by a review board from the institution giving the therapy.

The problem is that they don't have control groups, DLima said. The patient is his own control. They document the patientss clinical condition before the treatment and then document the patient's clinical condition after the treatment. Most of the studies are fairly loosely designed and there's no active (effort) to get the patients back for follow up.

Patients should also consider the kinds of cells to be used, because some are higher risk than others, DLima said. Autologous cells are the safest, because theyre the patients own cells.

The most risk comes from using tissues grown from embryonic stem cells or a man-made equivalent called induced pluripotent stem cells. Thats because pluripotent stem cells can make nearly any type of tissue in the body. So any remaining pluripotent stem cells in transplanted tissues tend to form tumors called teratomas, disorganized masses of random tissue types, such as hair, brain, liver and bone. For these trials, FDA authorization is required.

Intermediate on the risk level are non-pluripotent stem cells, such those found in bone marrow or fat, taken from other people. The FDA must also approve these trials.

Lisa Kadyk, senior science officer for the California Institute for Regenerative Medicine, the states stem agency, listed a number of warning signs that a stem cell treatment might not be legitimate.

-- Slick websites and hyped claims of effectiveness

-- Large out-of-pocket costs to patients

-- Small stand-alone clinics not associated with hospital networks or other high profile medical groups

Kadyk said patients can get more extensive guidance from the International Society for Stem Cell Research. Go to j.mp/stemle for the information.

Using cautious wording, Kadyk said by email that it is possible that some autologous therapies, such as bone-marrow derived cells for arthritis, could produce a therapeutic benefit in some situations.

This possibility would explain anecdotal stories of benefit maybe sometimes these treatments really are helping patients, and in other cases they are not, Kadyk said.

A simple explanation for the difference in response is that one persons stem cells may not be as healthy or as able to repair as another persons stem cells, she said. This can be due to their genetic makeup, or simply due to aging as one ages, ones stem cells age as well, and become less functional. Or, the differences could be ascribed to differences in how the cells are isolated, how they are treated after isolation, and how they are administered back to the patient.

With unregulated therapies, there is no standard for any of this, so patients are taking a gamble, rather than having some assurance that the methods used have been proven to work effectively, she said.

bradley.fikes@sduniontribune.com

(619) 293-1020

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Baby Boomers turn to stem cells for help with painful joints - The San Diego Union-Tribune

Advance furthers stem cells for use in drug discovery, cell therapy – Medical Xpress

July 14, 2017 by David Tenenbaum In the lab of William Murphy at UW-Madison, these six experimental samples are substrates that were evaluated for their ability to support stem cells. The samples, each 1 millimeter in diameter, and contain subtle chemical and physical variations, affecting such factors as hardness, speed of breakdown, and points for cellular attachment. Inset shows a network of blood vessels generated for the new Nature Biomedical Engineering paper, based on stem cells that grew on one particular substrate. Credit: Credit: William Daly, Eric Nguyen and Mike Schwartz, UW-Madison

Since highly versatile human stem cells were discovered at the University of Wisconsin-Madison nearly 20 years ago, their path to the market and clinic has been slowed by a range of complications.

Both embryonic stem cells and induced pluripotent stem cells are valued for their ability to form any cell in the body.

This week, a UW-Madison team reports in Nature Biomedical Engineering that they have jumped a major hurdle on the path toward wider use of stem cells. Using an automated screening test that they devised, William Murphy, a professor of biomedical engineering, and colleagues Eric Nguyen and William Daly have invented an all-chemical replacement for the confusing, even dangerous materials, now used to grow these delicate cells. "We set out to create a simple, completely synthetic material that would support stem cells without the issues of unintended effects and lack of reproducibility," Murphy says.

Stem cells respond to chemical signals that trigger their development into specialized cells in the brain, muscles and blood vessels. In the lab, researchers use a "substrate" material that anchors the cells in place and allows the necessary signaling. Matrigel, currently the most popular of these substrates, is a complex stew derived from mouse tumors. "Matrigel can be a very powerful material, as it includes more than 1,500 different proteins," says Murphy, "and these can influence cell behavior in a huge variety of ways. Matrigel has been used as a Swiss army knife for growing cells and assembling tissues, but there are substantial issues with reproducibility because it's such a complex material."

And given its biological origin, Matrigel can carry pathogens or other hazards.

In an advance that has already been granted two U.S. patents, Murphy's group has developed new substrates for:

The widespread toxicity of drugs to developing blood vessels is one reason why so many drugs cannot be used by women who may become pregnant. Blood vessel cells derived from stem cells could also provide a new method to screen environmental chemicals for vascular toxicity, which explains why the Environmental Protection Agency has funded Murphy's work, alongside the National Institutes of Health.

To find an improved chemistry that would hold and support stem cells as they change into specialized cells, Murphy used robotic instruments to squirt arrays of more than 100 materials on a glass slide. "We developed a process that allowed us to test an array of materialseach one slightly different in terms of stiffness or ability to attach to stem cellson a single slide," he says. "It was automated, using a liquid-handling robot, and we could screen hundreds of materials in a month; which we can now do in a week."

In the "olden days," Murphy says, each experiment would only be able to screen about 10 materials, which means that their current weekly screen would have taken years.

A UW-Madison spinoff called Stem Pharm has licensed patents for the materials from the Wisconsin Alumni Research Foundation and is starting to sell the system to pharmaceutical companies and scientific institutes, says Murphy, who is Stem Pharm's co-founder and chief science officer. "Increasingly, pharmas are externalizing innovation, because internally they don't have as much capacity to innovate as before," Murphy says. "A number of companies have expressed a strong interest in moving away from Matrigel, and our vascular screening product has already been successfully beta tested at multiplelocations."

Finding a better growth substrate for stem cells may seem less sexy than identifying the cells in the first place, but it's one of the roadblocks that must be cleared so these ultra-flexible cells can realize their potential, says Murphy, who is co-director of UW-Madison's Stem Cell and Regenerative Medicine Center. "The next step in delivering on the promise of human stem cells involves more effectively manufacturing the cells themselves, and the tissues they create. We have shown that simple materials can serve as the chisels and hammers of stem cell manufacturing."

Explore further: Broken UV light leads to key heart muscle cell discovery

More information: Eric H. Nguyen et al. Versatile synthetic alternatives to Matrigel for vascular toxicity screening and stem cell expansion, Nature Biomedical Engineering (2017). DOI: 10.1038/s41551-017-0096

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Advance furthers stem cells for use in drug discovery, cell therapy - Medical Xpress

Dog Gets Special Stem Cell Treatment To Relieve Pain CBS Denver – CBS Local

July 13, 2017 1:15 PM

BROOMFIELD, Colo. (CBS4) Stem cell therapy isnt just for people. A dog received the treatment at the Aspen Arbor Animal Hospital in Broomfield on Wednesday.

(credit: CBS)

The patient 10-year-old Jenni is a Newfoundland mix with arthritis in her hips and elbows and veterinarians say the procedure is a minimally invasive way to treat her constant pain.

These are her stem cells that already are existing in her body and were just isolating them and putting them back in where theyre needed, said lab tech Darah Johnson.

The relief can last up to two years, according to vets. The techical name of the procedure is acti-stem cell therapy, and it is described by MediVet Biologics as follows:

MediVets stem cell therapy surpasses any other treatment options for elbow or hip dysplasia and arthritis in dogs and cats. Stem cells rebuild the cartilage in joints and reduce painful inflammation naturally. They are healing cells, naturally found throughout the body. The stem cells that are used in MediVets Acti-Stem Cell Therapy procedure are derived from the patients own fat, during a minimally invasive procedure. Once separated from the fat, a serum rich in the pets own healing stem cells is injected into the joints. The concentrated amount of stem cells in the damaged joint, simultaneously rebuild the cartilage and reduce painful inflammation. Repairing the arthritic joints eliminates the need of costly, ongoing pain medication and joint supplements for the dog.

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Dog Gets Special Stem Cell Treatment To Relieve Pain CBS Denver - CBS Local

Dad Of The Year Is Selling His WRX STI To Pay For Daughter’s … – Jalopnik

Jonathan Corbett from New York loves his Subaru WRX STI. But he loves his daughter more. In what comes off at first as a typical Craigslist ad, he closes by mentioning the car for sale is to raise money for stem cell therapy that he hopes will help heal his 5-year-old daughters brain, which suffered damage during birth.

As America debates how best to cover peoples health care needs, its a reminder of what some peopleeven diehard gearheads like uswill do to help the people they love.

Jonathans daughter Colleen was born in October, 2011 after an arduous 22 hour delivery that required the use of a vacuum, and that ultimately resulted in a blood infection and subsequent blood transfusion, subdural hematoma (bleeding of the brain), and two major seizures.

With injuries to her left and right frontal lobes, Colleen has since been diagnosed with level two cerebral palsy and bilateral hearing loss, and may also have cortical visual impairment. She regularly has seizures, and to get around, she uses a walker and a wheelchair.

But despite all that, Jonathan told Jalopnik his daughter is a fighter who loves music, and whos never afraid to show that shes a sassy, stubborn, loving cuddle bug.

As for the Subaru (a hatchback that the car enthusiast chose a year and a half ago in part because it could carry his daughters wheelchair and other equipment), its on its way out to help pay for stem cell therapy thats being offered by a clinic near Los Angeles. This $6,500 treatment, Jonathan told me over the phone, uses stem cells from umbilical cord blood to fix damaged cells or to grow new ones.

Jonathan says that, even though he has a Youcaring support site, the $7,500ish hed get from selling the Subi (he still owes over $12,000 on the car) could help get his daughter care more quickly, and it could also fend off some of those bills in the mailbox.

Jonathans Craigslist postingin which he mentions his daughters condition only briefly at the enddescribes a true enthusiasts car with a number of performance modifications, including a Cobb downpipe, SPT Exhaust, Cobb Accessport, and Eibach sway bars. They all seem like quality, sensible mods, and definitely not the work of a boyracer STI owner only looking to throw down mega power numbers.

To help me verify the story, Jonathan put me in touch with Colleens elementary school one-on-one assistant, who had nothing but praise for Jonathan and his beautiful and sweet little girl.

Therapy for that beautiful and sweet little girl is worth offloading a 305-horsepower, all-wheel drive rally machineof that there is no doubt. Still, its never easy getting rid of a car, especially one as great as the last-generation WRX STI, and especially one that youve hooned around Watkins Glen (see photo below). So this move speaks volumes about this guys dad-ing skills.

So if anyone near Camillus, New York is looking for a tastefully modified WRX STI, nows your chance. At $20,000, it actually seems like a good deal from a very good dad.

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Dad Of The Year Is Selling His WRX STI To Pay For Daughter's ... - Jalopnik

New Diabetes Treatment Teaches Rogue Immune Cells to Behave – Carlisle Sentinel

FRIDAY, July 14, 2017 (HealthDay News) -- A treatment targeting wayward immune cells in people with type 1 or type 2 diabetes may help even years later, a new study finds.

For the treatment, researchers take blood from a person with diabetes and separate out the immune system cells (lymphocytes). They briefly expose those cells to stem cells from umbilical cord blood from an unrelated infant. Then they return the lymphocytes to the patient's body.

The researchers have dubbed this treatment "stem cell educator therapy," because when exposed to the stem cells, the errant lymphocytes seem to re-learn how they should behave.

"Stem cell educator therapy is a safe approach" with long-term effectiveness, said the study's lead author, Dr. Yong Zhao. He's an associate scientist at Hackensack University Medical Center in New Jersey.

Type 1 diabetes, an autoimmune disease, occurs when the body's immune system cells mistakenly attack the insulin-producing (beta) cells in the pancreas. This leaves people with type 1 diabetes with little to no insulin. They need insulin injections to survive.

Researchers have long thought that any cure for type 1 diabetes would have to stop the autoimmune attack, while regenerating or transplanting beta cells.

But Zhao and his team developed a new approach to the problem -- educating the immune cells that had been destroying beta cells so they stop attacking.

In type 2 diabetes, Zhao said immune cell dysfunction is responsible for chronic inflammation that causes insulin resistance. When someone is insulin resistant, their body's cells can't properly use insulin to usher sugar from foods into cells for use as energy. Instead, the sugar builds up in the blood.

The researchers hoped the stem cell educator would help decrease insulin resistance for people with type 2 diabetes.

In earlier trials, the treatment showed significant promise with up to a year of data. The researchers also showed that the treatment was safe.

The current study looked at four years of data on nine type 1 diabetes patients in China.

To see how well the treatment works, the researchers measured C-peptide, a protein fragment that's a byproduct of insulin production.

Two people with type 1 diabetes who received a stem cell educator treatment shortly after diagnosis (five and eight months later) still had normal C-peptide production and didn't need insulin four years after a single treatment.

Another type 1 patient had had the disease for four years when she got a treatment. She still had improvements in her C-peptide levels, but wasn't considered in remission. The remaining six people with type 1 saw decreases in their C-peptide levels over time. The study authors said this suggests more than one treatment might be needed.

"Because this was a first trial, patients just got one treatment. Now we know it's very safe so patients can receive two or three treatments," Zhao said.

Researchers also looked at six patients with severe, long-standing (15-24 years) type 2 diabetes. They found that one treatment helped four patients achieve normal C-peptide levels and maintain them over the four-year follow-up.

"For the four type 2 patients, their C-peptide is very stable after one treatment," Zhao said.

In addition to helping people with diabetes, Zhao said the treatment could help with other autoimmune diseases, too. These might include alopecia areata, which causes significant and sudden hair loss; lupus, Hashimoto's thyroiditis; and Sjogren's syndrome, he said.

Julia Greenstein is vice president of discovery research at JDRF (formerly the Juvenile Diabetes Research Foundation). She said Zhao and his team have shown that the "platelets seem to be having a direct effect on the beta cells," boosting the beta cells somehow.

"This research is intriguing, but it needs to be reproduced," she said.

Both Zhao and Greenstein noted that diabetes seems to differ slightly in Chinese populations from Western ones. So, it's not yet clear if this treatment would be as beneficial for people of European descent.

To find out, Zhao plans to conduct a clinical trial of the new treatment with people with type 1 diabetes at Hackensack Medical Center.

The study was recently published in Stem Cells Translational Medicine.

Learn more about type 1 diabetes from JDRF.

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New Diabetes Treatment Teaches Rogue Immune Cells to Behave - Carlisle Sentinel

Duterte ‘gumagwapo’ but spokesman says as far as he knows President didn’t undergo stem cell therapy – InterAksyon

MANILA, Philippines Other leaders reportedly or admittedly did it former presidents Joseph Estrada and Gloria Macapagal-Arroyo, ex-senator Juan Ponce Enrile, and former first lady Imelda Marcos.

And maybe theres nothing wrong if President Rodrigo Duterte had also underwent stem cell therapy.

But while Dutertes spokesperson said that the chief executive appeared to be looking younger and more attractive nowadays, Ernesto Abella on Friday, July 14, said that he didnt receive any information to confirm swirling speculations that Duterte had underwent the procedure done through therapies such as transplantation of blood stem cells, bone marrow transplant, or the use of umbilical cord blood.

He looks guwapo [handsome], right?, Abella told reporters but added that as far as he knew, the President didnt undergo such treatment also known as regenerative medicine that treats or prevents a disease or condition and helps repair body organs.

Abella nonetheless admitted that what he knew about the matter was limited so far.

On Wednesday, July 13, Presidential Communications Secretary Martin Andanar sidestepped a query on reports about the same issue.

Instead of answering the question, Andanar said during a radio interview on dzRH that, You know, when we started last year, (the President) attended 1,355 activities in his first 365 days in Malacaang, the Peoples Palace. Thats an average of four activities a day.

We can see how industrious President Duterte is he just continues to do what he is doing. He is working hard for the country, and he is working hard for the people, he added.

The reports came out following Dutertes frequent absence from public view since last month.

Last June 28, Duterte told the public that they would see less of him until the crisis in Marawi ends.

May mga lakad akong di nyo dapat malamanPagkatapos na siguro [I will have trips that you should not know aboutMaybe after], when Im through with this job, then Ill tell you everything, he said.

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Duterte 'gumagwapo' but spokesman says as far as he knows President didn't undergo stem cell therapy - InterAksyon

New NUH study to test stem cells as treatment for liver disease … – TODAYonline

SINGAPORE The use of stem cell treatment to repair liver cirrhosis, or hardening of the liver, will be tested in a clinical trial here involving 46 patients and costing S$2.6 million.

The four-year study, which was launched yesterday, came amid a growing waiting list in Singapore for a liver transplant, which is currently the only cure for patients with end-stage liver cirrhosis.

Conducted by a multi-centre team from several restructured hospitals here, the study is led by the National University Hospital (NUH).

Liver failure is one of the top 20 causes of death in Singapore, but many patients are not suitable for a transplant due to factors such as age and surgical fitness.

Out of every five patients doctors see with end-stage liver disease, only one qualifies for a liver transplant, said Dr Dan Yock Young, principal investigator of the clinical trial and senior consultant at NUHs division of gastroenterology and hepatology.

(A liver transplant) is curative, but it is a complex procedure, and many patients are not suitable for it. For these patients, treatment is limited, but morbidity and mortality rates are high as high as 50 per cent in one year and this is probably worse than many (of the) other terminal illnesses we talk about today, he said.

Animal studies conducted over the last five years have shown that stem cells can reconstruct the micro-environment of a normal liver.

Like how branches are of critical importance in supporting the leaves and fruits of a tree, the endothelial (stem) cells contribute to supporting a nutritious environment for the hepatocyte (liver) cells, Dr Dan explained.

While similar stem-cell studies have been conducted in other centres in Asia, there has been no definitive evidence of the benefits of the treatment for liver patients.

The study will recruit 46 patients aged between 40 and 70 years old, and who are at the terminal stages of chronic liver disease, over three years. It is funded by the National Medical Research Council.

During the clinical trial, patients will be divided into a therapeutic group and a control group.

All patients will receive an injection to stimulate their bone marrow cells as part of the supportive treatment for their liver cirrhosis. However, only patients in the study group will have the stem cells from the bone marrow extracted and deposited directly into their liver for more targeted repair.

Using ones own stem cells will avoid the problem of cell rejection.

The liver tissue will be examined three months later, and an investigation to compare pre- and post-transplant results will be conducted after a year.

Since invasive surgery is not required for stem-cell therapy, the fatality risk is significantly lowered for the patient. However, other risks such as severe bleeding and infections still remain, given the patients weakened condition.

NUH also noted that the stem-cell therapy does not replace liver transplants, and the latter remains the best available treatment for liver cirrhosis.

It is very painful to turn patients away when we cannot offer them a liver transplant, said Dr Dan, adding that this stem cell therapy will serve as an alternative option.

We hope that this is a stepping stone to trials for stem cell candidates, he added.

MORE WAITING FOR A LIVER

The number of people on the waiting list for a liver transplant has been growing in recent years. In June last year, it was reported that there were 54 people on the list, more than double the 24 patients in 2011.

Chronic Hepatitis B remains the primary cause of non-alcoholic fatty liver disease, which refers to a range of liver conditions affecting people who drink little to no alcohol. However, obesity has become a contributing factor to the illness as well.

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New NUH study to test stem cells as treatment for liver disease ... - TODAYonline

‘Stem-cell tourism’ needs tighter controls, say medical experts – The … – Washington Post

By Reuters By Reuters July 8

Stem cell tourism in which patients travel to developing countries for unproven and potentially risky therapies should be more tightly regulated, according to a group of international health experts.

With hundreds of medical centers around the world claiming to be able to repair tissue damaged by conditions such as multiple sclerosis and Parkinsons disease, tackling unscrupulous advertising of such procedures is crucial.

These therapies are advertised directly to patients with the promise of a cure, but there is often little or no evidence to show they will help or that they will not cause harm, the 15 experts wrote in the journal Science Translational Medicine.

Some types of stem cell transplant mainly using blood and skin stem cells have been approved by regulators after full clinical trials found they could treat certain types of cancer and grow skin grafts for burn patients.

But many other potential therapies are only in the earliest stages of development and have not been approved by regulators.

Stem cell therapies hold a lot of promise, but we need rigorous clinical trials and regulatory processes to determine whether a proposed treatment is safe, effective and better than existing treatments, said one of the 15, Sarah Chan of Britains University of Edinburgh.

The experts called for global action, led by the World Health Organization, to introduce controls on advertising and to agree on international standards for the manufacture and testing of cell- and tissue-based therapies.

The globalization of health markets and the specific tensions surrounding stem cell research and its applications have made this a difficult challenge, they wrote. However, the stakes are too high not to take a united stance.

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'Stem-cell tourism' needs tighter controls, say medical experts - The ... - Washington Post

A tall order: Giraffe receives stem-cell therapy for chronic arthritis – Source

How do veterinarians help a giraffe ease its arthritis pain? Well, it takes a little more than an aspirin and a gulp of water.

Recently, Colorado State University veterinarians traveled to Cheyenne Mountain Zoo to help Mahali, a 14-year-old giraffe, with arthritis pain in his front left hoof.

Arthritis is a common problem for giraffes, especially geriatric giraffes like Mahali. Who can blame them? Weighing in at 2,000 pounds on average, their four feet support more than one ton of weight. Thats like carrying two grand pianos on your back all day.

With its 17-giraffe herd trained for voluntary husbandry, including hoof trims, blood draws and radiographs, Cheyenne Mountain Zoo is uniquely suited to help find better arthritis treatments for giraffes.

Dr. Amanda Morphet, who is training to specialize in exotic and zoo animal medicine at CSU, believes stem-cell therapy can help alleviate arthritis pain.

Currently, arthritis in these megavertebrates is managed through corrective hoof trims, non-steroidal anti-inflammatories, cold-laser therapy and pain medications. But, these practices are not always enough to keep giraffes, which can live up to 30 years, comfortable as they age.

CSU veterinarians Dr. Val Johnson and Dr. Amanda Morphet, and the zoos lead veterinarian Dr. Liza Dadone, are determined to discover a more successful way to treat these gentle giants, and they believe stem-cell therapy is the answer.

Stem-cell therapy has resulted in dramatic clinical improvement in some cases of arthritis in horses and other species, but has not, until now, been attempted in giraffes, Johnson said.

The university and the zoo began working together seven years ago, when CSU veterinarian Dr. Matt Johnston and zoo veterinarians initiated a partnership to treat zoo animals while teaching veterinary students.

This specific stem-cell research partnership began in 2016, when Johnson and Dadone started treating a geriatric elephant for arthritis with stem-cell therapy.

Johnson, who is researching regenerative medicine at CSU, has safely treated a mountain lion, tiger, wolf, coyote and dogs with stem cells over the past five years.

Regenerative medicine is a promising new avenue for treatment of chronic age-related degenerative diseases, Johnson said. I want to develop more effective methods for treating animals.

Johnson and Dadone ran a crowdfunding campaign to develop a technique to grow stem cells from giraffe blood and grow multiple treatments of stem cells. The online campaign was quickly funded.

Cheyenne Mountain Zoo staff and veterinarians use hoof-trimming techniques on giraffes to maintain foot health and help prevent foot arthritis in older giraffes. (Photo by Andrew Schroeder)

In April, Morphet and Johnson traveled with two CSU anesthesiologists, Dr. Marlis Rezende and Dr. Khursheed Mama, to Colorado Springs for the procedure on Mahali.

Mahali was in pain. He wouldnt leave pressure on his front left foot for longer than a minute or two, said Morphet, who is training to specialize in exotic and zoo animal medicine at CSUs James L. Voss Veterinary Teaching Hospital.

Mahali is trained for general footwork, but injecting stem cells requires absolute stillness. Anesthetizing a giraffe, however, is especially dangerous for the animal.

With the length of the neck and limbs, falling during induction and recovery is a big concern, Dr. Morphet said.

The large procedure room was packed tight with veterinarians, zoo staff and volunteers who assisted Mahali, which included repositioning his body, and elevating his head at different angles every 10 minutes to prevent muscle spasms, aspiration and brain swelling. The team of volunteers scooped sand under his back to help Mahali roll up once he awoke.

If this sounds like intense physical work, it is.

Veterinarians took radiographs and successfully injected stem cells while Mahali was anesthetized. Meanwhile, a farrier team trimmed his hooves.

The stem cells, which were grown from giraffe blood, were injected through a vein near Mahalis inflamed hoof. The cells remained at the injection site for 20 minutes to improve absorption into the hoof.

Under the watchful care of veterinarians and zoo staff, Mahali came out of anesthesia safely. And then, they waited six long weeks for the stem cells to take effect.

This was the first time a giraffe has received stem-cell therapy to treat arthritis. The big question: Did it work?

Six weeks after the procedure, Morphet and veterinary students visited Mahali for a check-up.

Weve seen a dramatic improvement in his clinical signs, Morphet said. Not only to his comfort level but the quality of his hoof. Hes letting us work with his feet.

Dadone, the zoo veterinarian, used a thermal camera to view the heat distribution in Mahalis feet.

With the thermal imaging, you can see hot spots in the limbs, said Kara Gendron, a fourth-year veterinary student. The warmer it is, the more likely its inflamed and painful. His left hoof was still a little warmer, but compared to what we were seeing initially, it was very similar to his right [hoof]. So, hes actually doing a lot better.

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A tall order: Giraffe receives stem-cell therapy for chronic arthritis - Source

Clinical trial for stem-cell therapy to reverse liver cirrhosis – The Straits Times

SINGAPORE - The use of stem cells to reverse liver cirrhosis - or the hardening of the liver - is being explored in a clinical trial.

Conducted by a multi-centre team led by the National University Hospital (NUH), doctors aim to determine if stem cell therapy can improve liver function.

Previously, liver cirrhosis, caused by various diseases such as chronic hepatitis B and non-alcoholic fatty liver disease, was thought to be irreversible.

A liver transplant provides a definitive cure to end-stage cirrhosis.

However, in Singapore, less than 5 per cent of end-stage liver cirrhosis patients receive a liver transplant.

The number of people on the waiting list for a liver transplant has been increasing over the years, according to statistics from the Ministry of Health.

In 2007, there were nine on the waiting list, compared with 57 last year. There are around 50 waiting for a liver transplant this year.

Also, many patients do not fulfil the eligibility criteria to receive a liver transplant due to other health complications or being above the age limit of 70 years.

The $2.6 million study, which was launched on Tuesday (July 11),is funded by the National Medical Research Counciland 46 patients will be recruited for it. It will run for four years and patients will not need to bear the costs of the stem cell treatment.

Stem cells will be taken from a patient's own bone marrow and will be isolated and injected directly into the patient's liver to initiate the repair.

Similar therapy treatments have been conducted overseas in countries such asEgypt and India, although they have not been fully evaluated for efficacy.

Associate Professor Dan Yock Young, a senior consultant in the division of gastroenterology and hepatology at NUH, said: "We are conducting the study in a systematic and scientific mannerto get definitive evidence of the effects of the treatment."

He also notes that the stem cell therapy is not a substitute for a liver transplant. "This treatment is not intended to pull patients off the waiting list, but provide an option for those who are not eligible for a transplant."

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Clinical trial for stem-cell therapy to reverse liver cirrhosis - The Straits Times

Stem cell-based therapy for targeting skin-to-brain cancer – Medical Xpress

July 10, 2017 Credit: CC0 Public Domain

Investigators from Brigham and Women's Hospital (BWH) and the Harvard Stem Cell Institute have a potential solution for how to kill tumor cells that have metastasized to the brain. The team has developed cancer-killing viruses that can deliver stem cells via the carotid artery, and applied them to metastatic tumors in the brain of clinically relevant mouse models. The investigators report the elimination of metastatic skin cancer cells from the brain of these preclinical models, resulting in prolonged survival. The study, published online this week in the journal PNAS, also describes a strategy of combining this therapy with immune check point inhibitors.

"Metastatic brain tumors - often from lung, breast or skin cancers - are the most commonly observed tumors within the brain and account for about 40 percent of advanced melanoma metastases. Current therapeutic options for such patients are limited, particularly when there are many metastases," says Khalid Shah, MS, PhD, director of the Center for Stem Cell Therapeutics and Imaging (CSTI) in the BWH Department of Neurosurgery, who led the study. "Our results are the first to provide insight into ways of targeting multiple brain metastatic deposits with stem-cell-loaded oncolytic viruses that specifically kill dividing tumor cells."

In their search for novel, tumor-specific therapies that could target multiple brain metastases without damaging adjacent tissues, the research team first developed different BRAF wild type and mutant mouse models that more closely mimic what is seen in patients. They found that injecting patient-derived, brain-seeking melanoma cells into the carotid artery of these preclinical models resulted in the formation of many metastatic tumors throughout the brain, mimicking what is seen in advanced melanoma cancer patients. The injected cells express markers that allow them to enter the brain and are labelled with bioluminescent and fluorescent markers to enable tracking by imaging technologies.

To devise a potential new therapy, the investigators engineered a population of bone marrow derived mesenchymal stem cells loaded with oncolytic herpes simplex virus (oHSV), which specifically kills dividing cancer cells while sparing normal cells. Previous research by Shah and his colleagues shows that different stem cell types are naturally attracted toward tumors in the brain. After first verifying that stem cells injected to the brain would travel to multiple metastatic sites and not to tumor-free areas in their model, the team injected stem cells loaded with oHSV into the carotid artery of metastasis-bearing mice.. Injecting the stem cells loaded with oHSV into the carotid artery, a likely strategy for clinical application, led to significantly slower tumor growth and increased survival, compared with the models that received unaltered stem cells or control injections. The oHSV loaded stem cells are ultimately killed by oHSV mediated oncolysis, preventing the engineered cells from persisting within the brain, which is an important safety component in the therapeutic use of these stem cells.

Due to an increasing body of evidence which suggests that the host immune response may be critical to the efficacy of oncolytic virotherapy, Shah and his colleagues also developed an immunocompetent melanoma mouse model and explored treating with both stem cell loaded oHSV and immune checkpoint blockers such as the ones that target the PD-1/PD-L1 pathway. They found that PD-L1 immune checkpoint blockade significantly improved the therapeutic efficacy of stem cell based oncolytic virotherapy in melanoma brain metastasis.

"We are currently developing similar animal models of brain metastasis from other cancer types as well as new oncolytic viruses that have the ability to specifically kill a wide variety of resistant tumor cells," said Shah, who is also a professor at Harvard Medical School and a principal faculty member at the Harvard Stem Cell Institute. "We are hopeful that our findings will overcome problems associated with current clinical procedures. This work will have direct implications for designing clinical trials using oncolytic viruses for metastatic tumors in the brain."

Explore further: Stem-cell-based therapy promising for treatment of breast cancer metastases in the brain

More information: Wanlu Du el al., "In vivo imaging of the fate and therapeutic efficacy of stem cell-loaded oncolytic herpes simplex virus in advanced melanoma," PNAS (2017). http://www.pnas.org/cgi/doi/10.1073/pnas.1700363114

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Stem cell-based therapy for targeting skin-to-brain cancer - Medical Xpress

Stem Cell Treatments in Use at Clinics Worldwide Need Regulation … – Multiple Sclerosis News Today

Advertising forstem cell therapies not supported by clinical researchoftenmadedirectly to patients and sometimes promoted as a cure for diseases like multiple sclerosis or Parkinsons is a growing problem that needs to be addressed and regulated, a team of leading experts say, calling suchstem cell tourism potentially unsafe.

Stem cell tourism is the unflattering name given to the practice of encouragingpatients totravel outside their home country to undergo suchtreatment, typicaly at a private clinic.

The article, titledMarketing of unproven stem cellbased interventions: A call to actionandrecently published inthe journal Science Translational Medicine, was co-authored by scientistswith universities and hospitals in the U.S., Canada, U.K., Belgium, Italy, Japan, and Australia. It focuses on the global problem of thecommercial promotion of stem cell therapies and ongoing resistance to regulatory efforts.

Its authors suggest that a coordinated approach, at national and international levels, be focused on engagement, harmonization, and enforcement in order to reduce risks associated with direct-to-consumer marketing of unproven stem cell treatments.

Treatments involving stem cell transplants are now being offered by hundreds of medical institutions worldwide, claiming efficacy in repairing tissue damaged by degenerative disorders like MS, even thoughthose claim often lack or are supported bylittle evidence .

They alsonoted that the continued availability of these treatments undermines the development of rigorously tested therapies, and potentially canendanger a patients life.

The researchers emphasizethat tighter regulations on stem cell therapy advertising are needed, especiallyregarding potential clinical benefits. They support the establishment ofinternational regulatory standards for the manufacture and testing of human cell and tissue-based therapies.

Many patients feel that potential cures are being held back by red tape and lengthy approval processes. Although this can be frustrating, these procedures are there to protect patients from undergoing needless treatments that could put their lives at risk, Sarah Chan, a University of Edinburgh Chancellors Fellow and report co-author, saidin anews release.

Chan and her colleagues are also calling for the World Health Organization to offer guidance on responsible clinical use of cells and tissues, as it does for medicines and medical devices.

Stem cell therapies hold a lot of promise, Chan said, but we need rigorous clinical trials and regulatory processes to determine whether a proposed treatment is safe, effective and better than existing treatments.

According to the release, the report and its recommendationsfollowed the death of two children at a German clinic in 2010. The clinichas since been shut down.

Certainstem cell therapies mostly involving blood and skin stem cells have undergone rigorous testing in clinical trials, the researchers noted. A number of theseresulted in aprovedtreatments for certain blood cancers, and to grow skin grafts for patients with severe burns.

Information about the current status of stem cell research andpotential uses of stem cell therapiesis availableon the websiteEuroStemCell.

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Stem Cell Treatments in Use at Clinics Worldwide Need Regulation ... - Multiple Sclerosis News Today

Regenerating the Body With Stem Cells Hype or Hope? – Labiotech.eu (blog)

When the Japanese researcher Shinya Yamanaka managed to reprogram adult cells into an embryonic-like state to yield induced pluripotent stem cells (iPSCs), this was supposed to herald a revolution in regenerative medicine. But 10 years after their discovery, a therapeutic breakthrough is still outstanding.

The overall stem cell therapy field has failed today to show a very clear cut clinical benefit, told me Georges Rawadi, VP for Business Development at Celyad. The field now needs some significant success to attract attention.

Even though investors prefer placing their bets on the hot T cell therapies these days, some stem cell technologies such as iPSCs are starting to get traction as big industry players are exploring the territory. Last year, Bayer and Versant threw $225M into the pot to launch BlueRock Therapeutics, a regenerative medicine company that plans to develop iPSC-based therapies. A year before, Fujifilm spent $307M to acquire the iPSC company Cellular Dynamics.

Although a big success story is still lagging behind, recent advances in the field argue that stem cells indeed have the potential to translate into effective therapies for currently intractable diseases. Heres an overview of what biotechs stem cells are up to!

Stem cell treatment is not a new concept hematopoietic stem cells (HSCs) were described as early as the 1960s and bone marrow transplants have been used to treat blood cancer for decades.

The reason that we get excited about stem cell therapies comes from our experience with the hematopoietic stem cells. If you want to see what a mature stem cell therapy is like, you only need to look at bone marrow transplantation explained James Peyer, Managing Partner at Apollo Ventures, who has a Ph.D. in stem cell biology.

According to Peyer, the hematopoietic stem cell field is one of the most active areas in the stem cell world right now, mainly fueled by our advances in the gene editing space. Tools like CRISPR and TALEN allow for the genetic modification of a patients own bone marrow stem cells, which can then be expanded and returned to the patient for the correction of a genetic defect.

Last year, regulators gave green light to one of the first therapies of this kind. Strimvelis, developed by GSK, consists of an ex vivo stem cell gene therapy to treat patients with the very rare type of Severe Combined Immunodeficiency (SCID). Using the patients own cells avoids the risk of graft versus host disease (GvHD), which still affects around 30% of people receiving a bone marrow transplant.

Small wonder that the CRISPR companies, CRISPR Therapeutics, Editas, and Intellia are all active in this field, with preclinical programs in a number hematological diseases.

To date, the most prominent stem cells in the clinic are mesenchymal stem cells (MSCs), which are moving through more than 300 registered clinical trials for a wide array of diseases. These cells are able to form a variety of tissues including bone, cartilage, muscle or fat, and can be readily harvested from patients or donors for use in autologous or allogeneic therapies.

While MSCs have deluded the biotech scene with good safety profiles in clinical trials, their actual regenerative potential remains controversial, and there have been a great number of clinical failures, which many blame on a lack of demonstrated mechanisms of action.

As Peyer explained, The problem here is that, as opposed to other adult stem cells, the MSC has been unclearly defined. We know roughly what it does but we dont fully understand the molecular mechanisms driving these cells. On top of being unclearly defined, the regenerative powers of MSCs have been massively over-claimed in the past.

Another reason for the lack of clinical benefit has also been attributed to the use of undifferentiated MSCs, as Rawadi explained to me. The Belgian biotech Celyad, which has been pioneering cell therapy in the cardiovascular space, is using bone-marrow derived autologous MSCs and differentiates them into cardiomyocyte precursors to produce new heart muscle in patients with heart failure.

Although the company missed its primary endpoint in a phase III trial last year, Celyad has staked out a patient subpopulation that showed significant improvement. Its technology still has the confidence of the FDA, which just handed out a Fast Track designation and Celyad is now planning a refined Phase III trial.

One of Celyads major competitors, Australian Mesoblast, is forging ahead using allogeneic MSCs with Phase III programs in heart failure, chronic low back pain (CLBP) due to disc degeneration, as well as a range of inflammatory conditions including GvHD and rheumatoid arthritis.

Although the ability of MSCs to regenerate tissues remains questionable, the Mesoblasts approach hinges on a body of evidence showing that MSCs can suppress inflammation and mobilize endogenous repair mechanisms through indirect effects on immune cells.

Indeed, the first-ever approved stem cell therapy, Prochymal, also depends on this mechanism. Prochymal was developed by US-based Osiris Therapeutics and in 2012 received Canadian approval to treat acute GvHD. But after Sanofi opted to shelve its partnership with Osiris prior to FDA approval, the biotech sold out its off-the-shelf stem cell platform to Mesoblast in a $100M deal.

In Belgium, companies like TiGenix and Promethera are also banking on the immunomodulatory properties of MSCs. The companies are developing treatments for patients with Crohns disease and liver diseases, respectively.

The ultimate hope for stem cell therapies has been to regenerate damaged or diseased tissues as found in diabetes, heart failure or blindness. Holostem Terapie Avanzate, a spin-off from the University of Modena and Reggio Emilia was the first company to move towards this goal.

Building on 20 long years of research, the biotech has developed Holoclar, the first and only autologous stem cell therapy (apart from bone marrow transplants) to enter the European market. Holoclar is based on limbal stem cells, located in a part of the eye called the limbus, which can be used to restore eyesight in patients that have lost sight due to burn injuries.

Meanwhile, UK-based Reneuron is developing off-the-shelf therapies that aim to restore the cognitive function of patients following a stroke. Backed by no other than Neil Woodford, the company recently raised an impressive 100M to advance its lead therapy to the market.

The biotechs fetal-derived neural stem cell line CTX was able to significantly reduce the disability of post-stroke patients in a Phase II trial and ReNeuron is now planning to push its candidate into pivotal trials.

A major question in the space a decade ago was safety. Today, theres been a lot of trials done that show that safety is not an issue. I think safety is kind of off the table but efficacy is still a question mark. And thats what were trying to deliver now, Olav Helleb, CEO of ReNeuron, told me.

While neural stem cells and other tissue-specific stem cells are able to regenerate the cells of a particular tissue, Embryonic Stem Cells (ESCs) and their engineered counterparts, iPSCs, are capable of making every cell type in the body, a property known as pluripotency. Pluripotent stem cells can also expand indefinitely in culture and their identification unlocked massive expectations for these cells to transform the regenerative medicine field.

Yet, these cells come with significant challenges associated with the safety of the final preparation. Apart from ethical issues surrounding ESCs, today, a lot of companies have been cautious about using these cells for therapy, because undifferentiated pluripotent cells can drive tumor formation, explained Rawadi. Since ESCs can, in principle, form every cell type, they can lead to the formation of teratomas.

A major reason for the fairly slow progress in the field is based on the difficulties of directing a pluripotent cell to exactly the cell type that is needed for cell therapy. We can readily drive the cells from the undifferentiated state to the differentiated state. However, getting those cells to pause anywhere in the middle of this continuum to yield progenitor cells is incredibly challenging, Peyer explained. Another challenge, he says, is to engraft the cells in the right place to enable them to become fully integrated.

Besides initial hurdles, companies like US-based Asterias or ViaCyte are now running the first Phase I/II trials with ESC-derived cells to treat patients with spinal cord injuries and to restore the beta cells in type I diabetes. So far, the eye has been the the dominant organ for many of the first human clinical trials with pluripotent stem cells, where the cells are assessed in diseases such as age-related macular degeneration (AMD) to restore the loss of the retinal epithelium.

Deriving retinal epithelium from pluripotent cells is relatively easy and in fact, researchers in Japan are now running the very first clinical trial using donor-derived iPSCs to treat patients with AMD. For reasons of safety and standardization, the trial is based on an allogeneic approach. However, since this doesnt offer an exact genetic match, allogeneic therapies raise the prospect of immune rejection, an issue that has been plaguing the use of ESCs.

But the scientists in Japan have contended that iPSC banks could potentially solve this problem. The team in Japan is currently establishing an iPSC bank, consisting of HLA-characterized cell lines from 5-10 different donors, which should match 3050% of Japans population.

Such haplobanks have the benefits of allogeneic cell therapy, namely cost-effectiveness and standardization, but you still have matching immune systems, Peyer agrees.

For now, this remains a vision for the future, but the potential seems enormous. As Julian Howell, CMO of ReNeuron, told me, iPSCs have still got an awful long way to go. For the iPSC program running in Japan, they recently acknowledged that it took about $1.5M and 6 months to treat each patient. Its a great idea but its still got some way to go before it reaches the scale that could get into the clinic.

Images via nobeastsofierce,Natali_ Mis,vchal/ Shutterstock

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Regenerating the Body With Stem Cells Hype or Hope? - Labiotech.eu (blog)

Cell therapy may be key to treating Alzheimer’s & Parkinson’s – Economic Times

According to recent study, advancements in materials from this study could potentially help patients requiring stem cell therapies for spinal cord injuries, stroke, Parkinsons disease, Alzheimers disease, arthritic joints or any other condition requiring tissue regeneration. Earlier research revolved around the role of autoimmunity in terms of a treatment.

Its important in the context of cell therapies for people to cure these diseases or regenerate tissues that are no longer functional, shared Samuel I. Stupp, director of Northwesterns Simpson Querrey Institute for BioNanotechnology and Board of Trustees Professor of Materials Science and Engineering, Chemistry, Medicine and Biomedical Engineering.

Cells in our bodies are constantly being signalled with many types of instructions coming from proteins and other molecules present in the matrices that surround them. For example, these can be cues for cells to express specific genes so they can proliferate or differentiate into several types of cells leading to growth or regeneration of tissues. One of the marvels of this signalling machinery is the built-in capacity in living organisms to make signals stop and restart as needed, or to switch off one signal and activate a different one to orchestrate very complex processes.

Building artificial materials with this type of dynamic capacity for regenerative therapies has been virtually impossible so far. The new work published today reports the development of the first synthetic material that has the capability to trigger reversibly this type of dynamic signalling. The platform could not only lead to materials that manage stem cells for more effective regenerative therapies, but will also allow scientists to explore and discover in the laboratory new ways to control the fate of cells and their functions.

One of the findings is the possibility of using the synthetic material to signal neural stem cells to proliferate, then at a specific time selected by the operator, trigger their differentiation into neurons and then return the stem cells back to a proliferative state on demand. The paper also reports that spinal cord neural stem cells, initially grouped into structures known as neurospheres, can be driven to spread out and differentiate using a signal.

But when this signal is switched off, the cells spontaneously regroup themselves into colonies. This uncovers strong interactions among these cells that could be important in understanding developmental and regenerative cues. The potential use of the new technology to manipulate cells could help cure a patient with Parkinsons disease. The patients own skin cells could be converted to stem cells using existing techniques.

The new technology could help expand the newly converted stem cells in vitro in the lab and then drive their differentiation into dopamine-producing neurons before transplantation back to the patient. In the new technology, materials are chemically decorated with different strands of DNA, each designed to display a different signal to cells.

People would love to have cell therapies that utilize stem cells derived from their own bodies to regenerate tissue. In principle, this will eventually be possible, but one needs procedures that are effective at expanding and differentiating cells in order to do so. Our technology does that, noted Stupp. While this process is currently only done in vitro with the vision of then transplanting cells, Stupp said in the future it might be possible to perform this process in vivo.

The stem cells would be implanted in the clinic, encapsulated in the type of material described in the new work, via an injection and targeted to a particular spot. Then the soluble molecules would be given to the patient to manipulate proliferation and differentiation of transplanted cells. The study was published in journal Nature Communications.

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Cell therapy may be key to treating Alzheimer's & Parkinson's - Economic Times

Human Neural Stem Cell Therapy for Chronic Ischemic Stroke – Genetic Engineering & Biotechnology News

Stem cells and stroke

The past decade has seena rise in the number of stem cell-derived therapies targeting ischemic stroke in preclinical and early clinical studies. Corroborated by numerous scientific reports, the therapeutic benefits of stem cells include an extension of the time window for drug intervention, improvement of neurological deficits, reduction of infarct volume, pro-regenerative cerebral reorganization, mitigation of poststroke neuro-inflammation, and tissue restoration, all of which depend on the time after infarct, cell type used, and route of administration13. The wide range of effects observed for stem cell therapies demonstrates that functional recovery after stroke occurs via multiple mechanisms rather than a single target46. Research indicates that the mode of action may depend on the stem cell type and other key factors, including infarct size and location, mode of intervention, and timing poststroke68. Thus, some understanding of the cellular, molecular, and biochemical events that are involved in the mode of action of a stem cell type is a prerequisite to improving and optimizing its therapeutic benefits.

Our 2012 review of cell therapy in stroke showed the wide variety of cell types used preclinically and clinically in stroke treatment research1. Mesenchymal stromal cells (MSCs) of multiple origins and phenotypes are most commonly employed in the literature and mainly applied systemically in high doses in acute stroke settings, because of their nonengraftment and potent drug-like biological activity. Neural stem cells (NSCs), by contrast, are multipotent cells that are derived from developing or adult brain tissue or differentiated from pluripotent cells such as embryonic stem cells (ESCs) or induced pluripotent stem cells (iPSCs) in culture. These stem cells have both capacity for engraftment and neural cell differentiation as well as potent biological activity and are delivered intracerebrally in smaller volumes and cell doses; we believe that they are more suitable in patients presenting with pre-existing chronic, stable disability. Currently, there is a growing number of hNSC-derived therapies in preclinical development for ischemic stroke (Table). Leading these therapies, ReNeuron's CTX0E03 cell line (CTX) has been evaluated in a first-in-human, single-center trial in patients with moderate-to-severe disability, 6 months to 5 years after ischemic stroke9. Currently, a Phase II stroke trial in patients with upper-limb disability, 312 months poststroke is underway across multiple sites in the United Kingdom (clinicaltrials.govNCT02117635). In this review, we summarize nearly 15 years of research behind the CTX line and discuss its mode of action together with implications for therapeutic potential in stroke disability.

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Human Neural Stem Cell Therapy for Chronic Ischemic Stroke - Genetic Engineering & Biotechnology News

Stem Cell Therapy: You can be sexually active again – Vanguard … – Vanguard

By David Ikudayisi

Stem Cell Therapy comes in different types. Embryonic Stem Cell Therapy involves the use of embryonic stem cells derived from the inner cell mass of a blastocyst, an early-stage pre-implantation embryo at 4 days old to around 12 days old, leading to the destruction of the blastocyst which raises ethical and religious issues. Therefore, this type of Stem Cell Therapy is not the focus of this piece. The focus is Adult Stem Cells (ADSCs) and Induced Pluripotent Stem Cells (iPSCs). iPSCs are produced in the laboratories by reprogramming adult cells to express embryonic stem cells characteristics whereas ADSCs are cells obtained from an adult patient who will also be the recipient of the same stem cells.

In the United States, we must transplant the cells back to the same patient on the same day, while in some countries, the stem cells can be cultured to increase the quantity of stem cells before transplanting them back to the same patient who donated them.

Stem Cell Transplantation is a complex process that needs the care of experts in Regenerative Medicine, a new speciality of medicine . In order to ensure that science remains as the vehicle for hope and not harm, the controversies associated with the legal, social and legal issues of certain areas of stem cells research and stem cells potential clinical applications must be carefully examined. Advancing treatment and care for patients to save a life is and must be the ultimate goal.

Regenerative Medicine helps people to naturally regenerate and rejuvenate their bodies from the different conditions they may be suffering from without using chemicals or the orthodox medicine we are used to, but Adult Stem Cells Platelet Rich Plasma (PRP), that is, blood plasma that has been enriched with platelets, and contains growth factors which may elicit the gathering of stem cells around the damaged region stimulating cellular proliferation and tissue regeneration. PRP can be used to promote healing of injured tendons, ligaments, muscles, joints and can be applied to various musculoskeletal problems. The process allows your own (autologous) stem cells to be re-introduced into/around areas of damage or chronic disease. As mentioned earlier, the extraction and transplantation of the stem cells are done on the same day in the United States. Bone marrow transplant has been the most widely used Stem Cell Therapy till date, but Adult Adipose-Derived (fat) Stem Cell Therapy is fast gaining popularity as fat harvesting is less invasive than bone marrow harvesting. You get more stem cells from fat than bone marrow, and fat stem cells are not age-dependent. Adult Stem Cell Therapy may hold answers to many questions and problems that we doctors believed had no solutions, especially neurological disorders. The therapy, with or without PRP, revitalizes and regenerates the body organs and systems; it also reverses and repairs many pending subclinical medical problems before they become apparent, including the diseases that are age-related. Generally, Adult Stem Cell Therapy is safe as shown by many published research reports and clinical trials. However, this does not guarantee that adverse effects cant occur if the treatment is done by physicians that are not properly trained.

The therapy has helped a lot of people all over the world to regain their lives from debilitating ailments and Nigerians are not left behind. There are people in Nigeria that were either wheelchair bound and walking with occasional use of a cane before but now walking without one; diabetes patients are able to have restoration of vision in their eyes, and some feel and look younger. It has helped chronic kidney disease patients in Nigeria that are on hemodialysis to either reduce the frequency of hemodialysis per week or like a patient that was recommended to have kidney transplant a year ago but who is now off hemodialysis and off diabetic medications, and remains stable for the past months. Men with Erectile Dysfunction are now feeling like young men again. I cannot but mention that the type of treatment protocol and dosage of stem cells used also play a role in the efficacy of the treatment, and not everyone will respond in the same manner. Most of the patients, in studies, showed improvements after the first treatment, and the few that needed second treatment went on to see great results after more treatments were done; needless to say that they were elated with the results. The only group of patients that will always need more than a couple of transplantation sessions are patients with neurological disorders. Latest researches and evidence-based studies showed the number of treatment sessions needed to get significant clinical results can decrease by adding Exosomes to the treatment sessions.

In a recently publication in Germany, the new concept, developed around 2010 of how stem cells works, was reinforced where it stated that most of the effects of stem cells are through the Paracrine effects, delivered by the Exosomes. Exosomes are extracellular cell-derived vesicles that are present in almost all biological fluids. When secreted by stem cells, Exosomes are those tiny communication vesicles that interact with surrounding cells, thereby creating therapeutic activity. This is called the Paracrine effect. The Paracrine soluble factors (communication vesicles) have specialized functions and play a key role in intercellular signaling and in the following properties immune modulatory, neuroprotective, anti-inflammatory, neurotrophic, angiotrophic, anti-apoptotic and anti-oxidatory. Stem cells also secrete other important proteins and cytokines that have healing properties.

There are some diseases that conventional treatments have no cure for, but Adult Stem Cell Therapy can reverse the symptoms of those diseases, repair and regenerate the damaged tissues or organs affected. In some cases, it significantly slows down the progression of the disorder. For example, it can regenerate the bony joints in arthritis, repair and strengthen partial rotator cuff tears and avascular necrosis of the hip without surgery, revitalize the sexual organs in men and women, regenerate renal cells in kidney diseases, modulate immune system without use of medications that have very serious side effects in conditions like Rheumatoid Arthritis, Lupus, Scleroderma, Crohns disease, etc. Another advantage is its application in neurological disorders like ALS and spinal cord injury.

Adult Stem Cell Therapy can gradually lower diabetic medications dosage and eventually may get the patients off diabetic medications. This is evidenced by stem cells in a hyperglycemic medium differentiating into pancreatic cells; therefore leading to increased development of new blood vessels, secretion of various products of the immune system, and upregulation of pancreatic transcription factors and vascular growth factor. This aids the pancreas to regenerate and boost its ability to produce insulin. In stroke patients, stem cells activate cells around the suffering brain tissue to catalyze rapid healing and to improve brain function, thereby restoring motor function. Until recently, it was believed that damage to the brain tissue was permanent. This is being challenged by the evidences of re-growth of brain cells and improvements of neurological function documented with the use of Adult Stem Cells.

A procedure called P-Shot for Men uses the PRP Therapy to resolve challenges relating to Erectile Dysfunction by regenerating the damaged tissues. It gives treated men the possibility of saving their relationships by increasing stamina, enjoying bigger and harder genitals, and eventually increasing the length and girth. Orgasm-Shot for Women, the regenerative medicine procedure for womens sexual function, leads to increased ability to have orgasm, better arousal from clitoris stimulation, decreased pain during intercourse, tighter vaginal opening, increased sexual desire and natural lubrication, and increased arousal from G-spot stimulation. In addition, because of the O-Shot rejuvenation capabilities, there is help available for women suffering from urinary stress incontinence without the need for invasive surgery.

Since the stem cells used are autologous, there is no risk of rejection of the stem cell transplant. Nevertheless, as with any procedure, there is a risk of infection which can be very minimal or non-existent if done under the right conditions. Adult Stem Cells Transplantation can also be considered by people looking for alternative treatments especially in the areas of diabetes, hypertension, kidney disease, female and male sexual dysfunction, joint pain, neurological disorder and autoimmune disease. The cost of treatment varies, and it is not for everyone. However, you cant place a price tag on life just as the saying goes that health is wealth.

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Stem Cell Therapy: You can be sexually active again - Vanguard ... - Vanguard

Consider risks of unapproved stem cell treatment – Kamloops This … – Kamloops This Week

Editor:

Re: (Stem cells to stem the wait? June 27):

There is a reason Health Canada has not approved certain stem-cell treatments: they have not been shown to work yet and even ones own minimally manipulated cells can be considered risky.

There is a great deal of research happening in Canada and globally and clinical trials are underway to test and improve the quality, safety and effectiveness of stem-cell therapies because scientists and industry believe they hold great promise.

As the KTW article noted, the federal government committed $20 million to the Centre for Commercialization of Regenerative Medicine in 2016, but it wasnt to establish a stem-cell therapy development facility in Toronto. Rather, the funding is to find better ways of manufacturing therapeutic cells, including stem cells, in the billions that are required for clinical use.

Not all stem cells are the same and it is crucial to ensure the purity of stem cells before they are injected into people.

There is a lot of support for stem-cell research and manufacturing in Canada and, if the public is patient, treatments will come.

For now, people seeking unapproved treatments should consider the risks (because they exist in the short-term and long-term) and be prepared to throw away their money if the treatment doesnt work.

Stacey Johnsondirector of communications and marketingCentre for Commercialization of Regenerative MedicineToronto

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Capricor yo-yos as J&J dumps stem cell partnership – FierceBiotech

After three and a half years, Johnson & Johnson is ducking out of a partnership with Capricor Therapeutics focusedon the use of stem cells to treat cardiovascular disease.

The decision by J&J's Janssen unit not to pursue a license comes as little surprise. The therapy at the center of their end-2013 dealCAP-1002 (off-the-shelf cardiosphere-derived cells)has already been marked up as missing the target in a phase 1/2 study involving patients who had suffered a heart attack, although the data remains under wraps.

Added to that, in April, interim results from a trial in Duchenne muscular dystrophy revealed promising activity, and prompted Capricor to upgrade the importance of the new indicationwhich lies outside the scope of its license with J&J.

The California biotech has already said it plans to start a second trial in DMD in the latter half of the year. But while the back-up indication is a comfort to investors, there is no question that the company will miss the financial backing from J&J, which included $12.5 million upfront and up to $325 million in milestone payments, as well as the kudos of a big pharma partner in a sector that has failed so far to live up to early promise.

Weak or scarred heart muscle is a major cause of heart failure, so using stem cells to repair scar tissue appears to be a logical way of improving outcomes. Attempts to show a benefit have met with marginal success, however. Last year for example, Celyad's 271-patient trial of its C-Cure stem cell therapy revealed no improvement compared to a sham procedure.

Capricor's CEO Linda Marbn, Ph.D. accentuated the positive of claiming full rights to CAP-1002, including not only the DMD data but also work with Janssen on developing a commercial-scale manufacturing process for the cell therapy, to which it now has a "fully paid-up nonexclusive license."

She also said it settled "uncertainty concerning the scope of the license for CAP-1002" and frees the company to seek partners elsewhere.

"We discussed potential product registration strategies for this indication at our recent meeting with the U.S. FDA, and we look forward to providing an update on our clinical development plans in DMD very shortly," continued Marbn.

Capricor also announced in an SEC filing that it is filingfor resale of up to 1.2 million shares of its common stock but would not be receiving any proceeds from the transaction. It ended the first quarter with $2.75 million in cash.

Shares in the biotech fell after the announcement but had rebounded at the time of writing, though they are still in penny stock territory at $0.80.

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Capricor yo-yos as J&J dumps stem cell partnership - FierceBiotech

Private clinics’ peddling of unproven stem cell treatments is unsafe and unethical – The Conversation AU

Stem cells have saved thousands of lives thanks to their applications in cancer treatments. Many other uses peddled by private clinics are without evidence.

Stem cell science is an area of medical research that continues to offer great promise. But as this weeks paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, are exploiting regulatory gaps to sell so-called stem cell treatments without evidence that what they offer is effective or even safe.

Such unregulated direct-to-consumer advertising typically of cells obtained using liposuction-like methods not only places the health of individuals at risk, but could also undermine the legitimate development of stem cell-based therapies.

Many academic societies and professional medical organisations have raised concerns about these futile and often expensive cell therapies. Despite this, national regulators have typically been slow or ineffective in curtailing them.

As well as tighter regulations here, international regulators such as the World Health Organisation and the International Council on Harmonisation need to move on ensuring patients desperate for cures arent sold treatments with limited efficacy and unknown safety.

Hundreds of stem cell clinics post online claims that they have been able to treat patients suffering from a wide range of conditions. These include osteoarthritis, pain, spinal cord injury, multiple sclerosis, diabetes and infertility. The websites are high on rhetoric of science often using various accreditation, awards and other tokens to imply legitimacy but low on proof that they work.

Rather than producing independently verified results, these clinics rely on patient testimonials or unsubstantiated claims of improvement. In so doing these shonky clinics understate the risks to patient health associated with these unproven stem cell-based interventions.

Properly administered informed consent is often overlooked or ignored, so patients can be misled about the likelihood of success. In addition to heavy financial burdens imposed on patients and their families, there is often an opportunity cost because the time wasted in receiving futile stem cells diverts patients away from proven medicines.

The many recent reports of adverse outcomes demonstrate the risks of receiving unproven cell therapies are not trivial. In the USA three women were blinded following experimental stem cell treatment for macular degeneration (a degenerative eye disease that can cause blindness). One man was rendered a quadriplegic following a stem cell intervention for stroke. And a woman whose family sought treatment for her dementia died in Australia.

Other notorious cases involving the deaths of patients include the German government shutting down the X-Cell Centre and the Italian government closing the Stamina Foundation it had previously supported.

At present, the only recognised stem cell treatments are those utilising blood stem cells isolated from bone marrow, peripheral blood (the cellular components of blood such as red and white blood cells and platelets) or umbilical cord blood.

Hundreds of thousand of lives have been saved over the last half-century in patients with cancers such as leukaemia, lymphoma and multiple myeloma, as well as rare inherited immune and metabolic disorders.

A few types of cancer and autoimmune diseases may also benefit from blood stem cells in the context of chemotherapy. Different stem cells are also successfully used for corneal and skin grafting.

All other applications remain in the preclinical research phase or are just starting to be evaluated in clinical trials.

Further reading: Yes theres hope, but treating spinal injuries with stem cells is not a reality yet

Often dismissed by for-profit clinics as red tape hampering progress, the rigour of clinical trials allows for the collection of impartial evidence. Such information is usually required before a new drug or medical device is released into the marketplace. Unfortunately, in the case of for-profit stem cell clinics, their marketing has gazumped the scientific evidence.

Action is required on many fronts. Regulators at both an international and national level need to tackle regulatory loopholes and challenge unfounded marketing claims of businesses selling unproven stem cell interventions.

Researchers need to more clearly communicate their findings and the necessary next steps to responsibly take their science from the laboratory to the clinic. And they should acknowledge that this will take time.

Patients and their loved ones must be encouraged to seek advice from a trained reputable health care professional, someone who knows their medical history. They should think twice if someone is offering a treatment outside standards of practice.

The stakes are too high not to have these difficult conversations. If a stem cell treatment sounds too good to be true, it probably is.

For more information on recognised stem cell treatments visit the National Stem Cell Foundation of Australia and Stem Cells Australia, Choice Australia, EuroStemCell, International Society for Stem Cell Research, and International Society for Cellular Therapy.

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Private clinics' peddling of unproven stem cell treatments is unsafe and unethical - The Conversation AU

Stem cell therapies: medical experts call for strict international rules – The Guardian

Stem cells have long been used to treat blood cancers and some immune diseases. But some doctors are offering stem cell treatments for diseases still under clinical trial. Photograph: Mauricio Lima/AFP/Getty Images

Medical and legal experts from around the world have united to call for more stringent regulation of stem cell therapies to prevent people pursuing unproven and potentially deadly treatments overseas.

In a perspective piece for the US journal Science Translational Medicine, 15 experts from countries including the UK, the US, Canada, Belgium, Italy and Japan wrote that national efforts alone would not be enough to counter an industry offering unproven treatments to vulnerable patients.

Stem cell-based interventions are classified under diverse and potentially incompatible national regulatory frameworks, the authors wrote.

Approaches for international regulation not only need to develop consistent rules over the commercialisation of medical practices and products but also need to give them teeth by developing cross-border partnerships for compliance.

Stem cells found in bone marrow and umbilical cord blood have long been used to successfully treat blood cancers including leukaemia and some immune diseases. But those are among the few proven treatments. Legitimate and ethics-approved clinical trials by academic centres are also occurring, exploring the potential of stem cells to treat a wider range of diseases.

But some doctors are directly offering to the general public stem cell treatments for diseases still under clinical trial or for which no evidence exists and for which the safety and efficacy is as yet unproven.

Deaths as a result of stem cell treatments have already occurred. In 2013 Sheila Drysdale died in a New South Wales nursing home after undergoing an unproven liposuction stem-cell therapy at a western Sydney clinic. Following Drysldales death, her doctor, Ralph Bright, gave a statement to police in which he claimed that stem-cell treatment could improve comorbidities and that stem cells could move from joints to other parts of the body to improve disease in distant sites including lungs and brain, vision, mentation and pain.

In his report into Drysdales death, the coroner Hugh Dillon wrote that he could not say what motivated Dr Bright to perform this unproven, dubious procedure on Sheila Drysdale.

But regardless of his motivation, Dr Brights performance as a medical practitioner was, for the reasons outlined above, poor and resulted in Sheila Drysdales death.

The Medical Council of NSW investigated Bright and placed a number of restrictions on his right to practice. Bright is still authorised to practise stem cell therapy for patients with osteoarthritis or who are taking part in research studies approved by an ethics committee. He is also still allowed to treat patients returning for remaining injections of stored cells.

In 2013 a Queensland woman, Kellie van Meurs, died when she travelled to Russia to undergo stem-cell treatment for a rare neurological disorder. She died of a heart attack as a result.

Australias drug regulator, the Therapeutic Goods Administration, last year sought feedback on the regulation of autologous stem-cell therapies but is yet to publish those submissions. A TGA spokeswoman said the Administration was still examining the options for changes to the legislation to reflect public and industry views. The TGA currently considers autologous treatments, which involve treating someone with their own tissue or cells, to be a therapeutic good and, therefore, does not regulate them. Stem cells used for medical practice and therapeutic purposes are covered by different regulatory frameworks.

Associate Professor Megan Munsie, a University of Melbourne stem cell scientist and a co-author of the paper, said: The idea that stem cells are magical holds court in the community, along with this idea the advances in treatment are being held up by red tape.

Unethical health practitioners exploited this, she said, along with the vulnerability of patients with difficult-to-treat or incurable conditions.

There is a precedent for international regulation of this industry because regulations already exist around drugs the way they are manufactured, she said.

This could be extended to the regulation to the stem cell and tissue-based therapies. This international stance would then force or encourage stronger local regulations.

There have been successful efforts by scientists to push back against unscrupulous doctors. In Italy scientists and regulators highlighted the unproven yet government-subsidised treatments being offered by the entrepreneur Davide Vannoni and fought to stop him. He was convicted of criminal charges but the sentence was later suspended.

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Stem cell therapies: medical experts call for strict international rules - The Guardian