“Latest Stem Cells News”

MENLO PARK, Calif., August 18, 2009 – Geron Corporation announced that its IND (Investigational New Drug application) for GRNOPC1, a cell therapy for neurologically complete, subacute spinal cord injury, has been placed on clinical hold by the FDA pending the agency’s review of new nonclinical animal study data submitted by the company. A clinical hold is an order that the FDA issues to a sponsor to delay a proposed trial or to suspend an ongoing trial.

Since filing the IND, Geron has been undertaking studies to enable dose escalation of its spinal cord injury product, and has been investigating application of the product to other neurodegenerative diseases. The company has also been performing additional product characterization and conducting further animal studies. Data from this work has been submitted to the FDA. Geron will work closely with the FDA to facilitate their review of the new data and to release the clinical hold. No patients have yet been treated in this study.

August 27, 2009 – Geron Corporation today provided additional comments on the recent clinical hold on its Spinal Cord Injury IND.

As biologic therapeutics advance in clinical trials, it is common practice to optimize product characteristics, improve manufacturing efficiency and scale, and to test the product in multiple disease models. As part of these ongoing efforts at Geron with respect to GRNOPC1, various animal studies were, and continue to be, performed to characterize the product’s effects in vivo. In previous animal studies of GRNOPC1 using materials that passed release specifications, a very low frequency of injected animals developed microscopic cysts in the regenerating injury site. These cysts were non-proliferative, confined to the injury site, and had no adverse effects on the animals. No animals developed teratomas or any other ectopic structure. Cysts of much larger size appear in the spinal cord scar tissue of up to 50% of patients with spinal cord injury.

A just completed animal study showed a higher frequency of cysts, although their characteristics were similar to the cysts seen in previous studies: non-proliferative, confined to the injury site, smaller than the injury cavity and not associated with adverse clinical outcomes.

As part of our ongoing product improvement efforts, new candidate markers and assays for product release have been identified that are linked with cyst formation across all animal studies in which cysts were found. Importantly, a manufactured lot of GRNOPC1 that was assessed using these markers and assays showed no cysts in another recently concluded animal study in spinal cord injured rats.

We have submitted these data to the FDA and are in discussions with the agency to answer its questions and proceed with the clinical trial. We are committed to the optimization of all our hESC-based products as we improve the manufacturing process and identify improved product release criteria.

from Geron

http://www.geron.com/media/pressview.aspx?id=1187

http://www.geron.com/media/pressview.aspx?id=1188

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Look what we have here- another stem cell research trial for heart disease (congestive heart failure) and another heart patient has his life improved. This time, at the University of Louisville, the first heart failure patient treated with his own Adult Stem Cells has improved already, just 2 week after his stem cell treatment.

Adult Stem Cells Result in 30% Improvement

Michael Jones, a contractor in Louisville, was the first congestive heart failure patient to take part in this stem cell research trial. Here is more from the stem cell article:

His severe congestive heart failure was treated with the stem cell treatment. The procedure involved injecting his own cardiac stem cells into his damaged heart muscle. It was done on July 17. He shows already had 20-30% improvement of his heart function since the treatment.

Congestive Heart Failure Kills Millions Every Year- US Does Nothing

Heart failure is a leading cause of death in the United States, affecting some 6 million Americans a year. Half of the patients die within one year. Doctors have had little to offer patients with late-stage heart failure. With major muscle damage to the heart, patients have the option of a heart transplant or implantation of a mechanically assisted heart device.

What About The Millions Who Can’t Get Stem Cell Treatment?

This is good news right? Well yes and no. Yes, I am happy for Michael Jones as he is a lucky man to receive stem cell treatment using his own adult stem cells and unsurprisingly it has worked.

No, because what about the other millions of Americans who aren’t able to receive this stem cell treatment. The Fight Aging Website has a post on this:

It is only in the last couple of years that clinical trials have started for autologous stem cell therapies in the US. Or, to put it another way, for some time now unelected and largely unaccountable employees of the US government have forbidden US residents – on pain of criminal prosecution – from offering or making their own decisions about a medical technology commercially available elsewhere in the world. All the while, these bureaucrats impose vast costs on medical development concerns by insisting on largely pointless trials, continuing far past any reasonable trade-off between risk and reward, thereby greatly postponing the commerical introduction of these technologies in the US.

Do you have responsibility for, or even the ability to make your own medical choices? Not according to people in positions of power at the FDA. Regulation in medicine has largely become an exercise undertaken for its own sake, as is the end result of any centralization of power. No-one’s interests are being served save for those of the career bureaucrats in charge of forbidding new things. Everyone else gets to suffer due to the ball and chain shackled to medical progress, and due to being forbidden the basic, fundamental freedom to choose how to treat their own medical conditions.

Now ask yourself, why can’t anyone with heart disease and the necessary funds just up and do the research on the treatment and choose to try this within the borders of the US? Because a faceless bureaucrat has decided that it is forbidden, and that anyone who offers this treatment must be jailed. Welcome to the land of the free.

This is similar to what I argued here in this stem cell research post

Stem Cell Treatment Information

For treatment information, please fill out this stem cell treatment form- and one of the Repair Stem Cell Institute’s staff will provide you with more information – free.

For full information, write me at donmargolis@gmail.com and just put “Treatment”  in the subject box. Or, if you want to start the process to treat a loved one now, fill out this stem cell treatment form and one of the Repair Stem Cell Institute’s staff will provide you with all the help you need -free.

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Recent stem cell research studies using Adult Stem Cells to treat heart diseases such as congestive heart failure and heart attacks have made the news recently.  And on the surface, these adult stem cell success stories of heart attack victims making amazing recoveries in these research clinical trials is wonderful news indeed.

New Research Trials for Heart Attack Victims

For example, at the Texas Heart Institute, John Hartman who had suffered a heart attack recently had his own stem cells implanted into his heart muscle in a new stem cell research trial.

From the stem cell article:

Dr. Jim Willerson President, Texas Heart Institute, said, “We think the improvement we see is largely from the blood flow increase salvaging the cells that are reversibly injured, allowing them to function normally.”

“That reflects in the patient being able to do better, walk further, breathe better,” said Dr. Emerson Perin St Luke’s, THI Cardiologist.

Stem Cell Trial for Congestive Heart Failure

Also, in another stem cell research trial at Vanderbilt, an unnamed 65 year old congestive heart failure patient was treated using his own Adult Stem Cells again.   Dr. David Zhao, director of the cath lab there said “The patients who stand to benefit from this approach include those whose coronary arteries are so diseased that nothing else could be done,”

What About Heart Disease Patients Who Can’t Get Adult Stem Cells?

However, the headlines don’t mention the millions who are suffering and dying after having heart attacks (1.25 million per year in the United States) and are in congestive heart failure and don’t have the opportunity to receive adult stem cell treatment because the FDA has classified a patient’s own stem cells as a drug- thus slowing down progress and starving heart patients of a “drug” with no side effects or ethical issues and only has upside.

For every Barry Brown or Kenneth Milles, heart attack victims who were lucky enough to get into a US stem cell research clinical trial using their own stem cells, there are millions of heart disease patients who do not have that opportunity. And for that, we have the FDA to blame.

And that is only addressing adult stem cell therapy for heart disease………what about the hundreds of other conditions that can be helped or improved by Adult Stem Cells?

Sad.

For more information on clinical research trials in the United States, go to the Clinical Trials website – www.clinicaltrials.gov

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Another congestive heart failure patient has been helped by stem cell research using adult stem cells. Terry Areford, 62, a multiple heart attack victim has been given a 2nd chance at life after receiving Vescell stem cell treatment to heal his heart muscle in Thailand.

Congestive Heart Failure Symptoms

Terry was dying. He was slowing down. He had the usual symptoms of congestive heart failure. He had shortness of breath. He could barely walk 50 feet slowly. However, Terry still had hope. His daughter came across the Vescell website and contacted them.

Adult Stem Cells From Your Own Blood

For those of you unfamiliar with Vescell stem cell therapy in Thailand, it is a process created by a company called Theravitae in which adult stem cells are removed from the patient’s blood (similar to a blood donation) and then multiplied into a therapeutic dose and then implanted into the patient’s heart muscle and/or coronary arteries.

But back to Terry’s stem cell story-

Before Vescell Treatment

• Ejection Fraction 10%
• Could barely walk
• Severe shortness of breath

After Adult Stem Cells Implanted

• Ejection Fraction at 45%
• Plays 3 rounds of golf per week
• No shortness of breath- outside chopping firewood

3 full 18 hole rounds of golf per week? No kidding Terry?  I am very happy for you.   Like many of the Vescell heart patients recently, Terry has become an adult stem cell advocate and wants other congestive heart failure patients to know that there is still hope out there.

You are welcome to call or email Terry  at 304-594-9377 or his email is bkareford@msn.com

Stem Cell Research in Thailand

This is the third stem cell research success story to come out of Thailand in the last month. See stories from heart attack victims and heart failure patients James Eilert and Andy Jordan as well.   Is anyone in the FDA paying attention to this?  Adult Stem Cells can be used now to help these heart patients with no side effects!  Why do they have to leave the United States for it?

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Barbro Lowed, a retired air hostess from London, England says that stem cell research using Adult Stem Cells removed from her bone marrow has given her her life back.  Barbro had previously been suffering from congestive heart failure before the stem cell treatment. The heart failure was caused by a faulty valve.

This research story starts with Barbro going into congestive heart failure because of a leaky heart valve.  Then in Barbro’s own words -

Unless it was repaired, my heart would steadily worsen, until it couldn’t function any more. Even though I needed the operation straight away, the NHS waiting list was two years, which really worried me.

After six months, with no sign of an operation date, I was getting desperate. I felt dizzy and lethargic all the time and couldn’t even walk to the local shops without struggling for breath.

When Free Health Care Isn’t Free Anymore

Ok, I will give the US FDA a day off and target Socialist (Free?) Healthcare today. Can you imagine needing an operation yesterday and having to wait 2 years?  That is shameful.   And this is what Obama has in mind for us? I hope not. But no more ranting- on with the stem cell story….

Finding A Stem Cell Doctor Who Used Her Own Adult Stem Cells

Barbro found Professor Andreas Zeiher in Germany who had been performing stem cell therapy using the patient’s own Adult Stem Cells for many years. Now this is where the story gets a little confusing (at least to me):

Stem Cell Therapy for Congestive Heart Failure

According to Barbro’s account, Dr. Zeiher implanted the stem cells into her heart valve which apparently improved both her valve and her congestive heart failure. But if you look at the article, then in part 2, Dr. Zeiher describes implanting the stem cells into the arteries to cure the heart failure and in turn the heart valve?

Very confusing, but the most important part of the story is that Barbro now has her life back thanks to being implanted with her own Adult Stem Cells.

How Do the Stem Cells Do That Thing They Do?

Also from the article is this interesting tidbit from Dr. Zeiher: Stem cells have this extraordinary ability to turn into other cells. They help the heart heal by encouraging the formation of new blood vessels, which brings more oxygen and nutrients to the heart muscle.

And as far as we know, unlike drug treatments, stem cell transplants have no undesirable side-effects. The process is also less risky than conventional open-heart surgery, as it doesn’t involve a general anaesthetic, which is always a concern with a heart failure patient.

You can read the full article here as it is very fascinating-  Stem Cell Research Article

This is the 2nd day in a row with a Heart Disease story helped by Stem Cell Research using a patient’s own stem cells. Yesterday we featured a Michigan man who also suffered from congestive heart failure.

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Christopher J. Centeno, M.D.

A leading adult stem cell therapy organization is warning the public that the Food and Drug Administration (FDA) has teamed up with the pharmaceutical industry to declare a person’s own stem cells to be a “drug” which can be regulated, thus slowing down the progress of these promising therapies by requiring years of clinical trials before use.
Dr. Christopher Centeno, of Regenerative Science, Inc. of Broomfield, Colo., realized what was happening when he was contacted by the FDA last summer about his work using a patient’s own stem cells to regenerate bone and cartilage.

“The FDA contends that if one cultures stem cells at all, regardless of the use of those cells, then it’s a prescription drug,” said Dr. Centeno.
By declaring adult stem cells to be a drug means subjecting each application to 7-10 years of clinical trials before approved use.

“So while your doctor could do all of this safely in a physician-run lab and begin treating a host of diseases, you have to wait 5-20 years for access to your own stem cells (as a drug),” Dr. Centeno said. (…)

“If we can treat your heart failure with your stem cells, send them to the lab down the street where they’ll process them, and we’ll put the cells back into you — that would dramatically and negatively compete with the big pharma embryonic stem cell business model,” he said.
Dr. Centeno, who established an organization to define guidelines and standards for adult stem cell research called The American Stem Cell Therapy Association (ASCTA), hired a team of lawyers last summer to challenge the FDA’s assertion.

It was during this process that they discovered a critical change had been made in 2005 to the agency’s definition of human cell tissue or tissue based products, known as HCT/P’s. This change is what now allows adult stem cells to fall into the category of a biological drug. (…)

By changing one simple phrase, the agency has given itself sweeping new powers to regulate stem cells as biological drugs. But this change is problematic for the FDA because it amounts to a new regulation, something they are not authorized to make without notifying the public and offering the public the opportunity to comment. (…)

“First, the FDA has itself acknowledged that there exists a low risk of the spread of communicable disease when adult stem cells are taken from the patient and re-implanted into that same patient. Moreover, if the FDA asserted its jurisdiction over any product or procedure which involved the slightest possibility of contamination, the FDA would thereby regulate every hospital and doctor’s office in the country. The sorts of contamination to which Ms. Peper refers are commonly called ‘infections.’ An infection is a medical complication, not a federal public health issue.”

Read more on The Bulletin

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