“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

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

If you have done any research on stem cell treatments abroad, you will undoubtedly read negative articles like this one on CNN from the mainstream media saying these companies are promising cures and are preying on the desperate, that these companies are selling “snake oil”   Nothing could be further from the truth.

The stem cell companies and stem cell doctors that are part of the Repair Stem Cell Institute offer patients a good chance at an improvement in the patient’s quality of life- they don’t offer nor promise cures.  Patients going to these stem cell therapy treatment centers abroad know this.

Unfortunately, the United States and their FDA don’t give these patients any other options.  Are they able to use their own stem cells to help their multiple sclerosis or heart disease-  Stem Cells that have been proven safe in thousands of studies? No.  What is one to do then?  These patients must go abroad for the only treatment that can help their disease or condition.

Here is a sampling of what some of these companies  affiliated with the Repair Stem Cell Institute tell their patients:

From Stem Cells China:

It’s not a cure. It’s about quality of life. Every day I see inquiries begin like this: “Can stem cells cure…?” Everyone should know the answer to that one right away. No. No known therapy utilizing stem cells can cure any medical condition. Not one.

A cure would rewrite the broken code of your genome. A cure would rewind the debilitating progression of a neuro-degenerative disease to the moment before onset. A cure would fix all the wrongs of a baby’s challenged birth. We eagerly await the development of cures and their accessibility to patients in need.

So why are people receiving stem cell therapy today? Therapies involving adult stem cells today are providing quality of life improvements for many patients. It’s no cure. Just as painkillers are not a cure for pain. They improve our quality of life if we feel pain.

But who would deny that painkillers are still worthwhile for extreme pain? Many doctors in the West are saying that they don’t have enough proof that stem cells are improving quality of life for patients. In the meantime, patients are busy coming to China and China’s stem cell clinics are busy offering the chance for quality of life improvements where none else would exist. We encourage you to explore the therapies being offered today.

From Dr. Shimon Slavin, Israel, helping people like Louis Zylstra and Arndt Roehlig

However, we have some positive and most encouraging evidence that the cells we inject may be of benefit, especially as evidenced in some patients with multiple sclerosis as well as based on the first patient we treated with spinal injury that seemed to have somewhat improved. The good news is that there are no side effects at all so there is no risk and nothing to lose (except money…). I would like to stress that since we are in very early stages of our research, nothing can be said about the clinical efficacy of our approach.  However, on the other hand, I do understand that patients in need cannot wait for all the answers to be solved and this is why we agree to offer experimental procedures for patients that understand the experimental nature of our program and consent to try and explore new treatment options.

From Dr. Roberto Fernandez Vina– For doctors who say that current stem cell therapies are “unproven,” Dr. Fernandez Viña has the following response:

“How many patients must to be treated to say this is a cure? How many patients must die waiting for the word “cure?”

A lot of diseases are not totally cured with drugs but the laboratories talk about curing (HIV, Tuberculosis and a lot of malignant deseases). They say that the drugs “cure” but in reality the drugs improve the quality of life. Stem cells “cure” in the same sense. If a person is dying of diabetes and we improve the prognosis and he no longer needs insulin injections, we increase the C peptide, decrease the HbA1c, decrease protein in the urine, decrease the risk of amputation or kidney failure, in my book that is a “cure.”

From Richard Humphries, with multiple sclerosis and a stem cell recipient from Cell Medicine in Costa Rica:

I’m case study #1 in the paper (Multiple Sclerosis Study) just released and have had two stem cell treatments in Costa Rica where they promise nothing but deliver wonderful results. Secondary Progressive Multiple Sclerosis patients can’t wait on historical data. Time is not on our side but stem cells improved my quality of life and the follow up MRI looks excellent.

From the X cell Center in Germany:

Even if not all of the interactions have been conclusively researched to date, the status of the current medical insights has indeed reached a level that allows the non- hazardous treatment with adult stem cells and puts medical professionals in a position to assume responsibility for its use.

Given the proven treatment success of regenerative medicine, the question of whether more research is needed prior to therapeutic use has already been answered.

Those who nevertheless demand stem cell therapy be postponed until we know more about it are taking away patients’ rights to make their own decisions as they search for medical solutions – for the kind of help stem cell therapy does offer.

SANTIAGO, Dominican Republic (CNN) — This Caribbean city already known for cigars, furniture, chocolate and coffee may become a magnet for Americans seeking controversial stem cell therapy for life-threatening illnesses if a Florida cardiologist has his way.

The Food and Drug Administration has not approved this stem cell therapy in the United States because no clinical trials to prove its effectiveness have been done. But Dr. Zannos Grekos says his company, Regenocyte Therapeutic, has successfully used adult stem cells to treat patients with heart and lung disease.

Grekos said he and his associates draw blood from a patient in Florida and then send it to a laboratory in Israel that produces what his company calls “regenocytes.” The company defines regenocyte as “a stem cell that has been activated to become a target organ.” (…)

But Grekos’ procedures have not been reviewed by other researchers, and leading scientists involved in U.S. stem cell research efforts say Grekos is simply wrong. Dr. Irving Weissman, president-elect of the International Society for Stem Cell Research, told CNN, “There is no such cell. There is nothing called a ‘regenocyte.’ ”

“As a stem cell scientist who works in the field of regenerative stem cells, I am disappointed and shocked that somebody would prey on a family that has an untreatable disease with the promise of a therapy that has no scientific or medical basis,” Weissman said.

Grekos has a busy practice in Bonita Springs, Florida, outside Naples, and runs a company that promotes and administers stem cell therapies in Santiago, a noisy, crowded industrial city in the central Dominican Republic.

He told CNN that in the past 18 months, about 100 patients have received adult stem cell therapy at a Dominican hospital. Most of them have been patients with severe heart disease, while the rest have suffered from chronic lung illnesses, he said.

He said the Israeli laboratories can produce between 40 million and 80 million stem cells from a patient’s blood sample (…)

The procedure is costly. Grekos said he charges $64,500 — none of it covered by insurance. He said the cost is driven by the expense of processing the stem cells, and providing clean rooms and couriers who hand-carry the cells to Israel and back.

A year ago, Barbara McKean of Naples, Florida, paid Regenocyte Therapeutic more than $54,000 for stem cell therapy in the Dominican Republic after suffering from chronic lung disease. She said she believes the therapy was worth the expense (…)

The chief medical officer of the American Lung Association, Dr. Norman Edelman, said he does not doubt the sincerity of patients who believe they have been helped by stem cell therapy. But he added, “There’s an enormous placebo effect in almost all of these cases.” (…)

Stem cell experts who reject his methods “need to be better educated,” he said.

read the full story on CNN

A woman from New York has written an open letter to Obama saying that stem cell research using Adult Stem Cells has helped her daughter’s autism. Judy DiCorcia is reporting that her daughter, Lauren, a 10 year old girl with autism has improved significantly after the stem cell treatment and therapy in Germany in January 2009.

Process of Stem Cell Research and Therapy for Autism

1. Bone Marrow Extracted From Patient
2. Using a centrifuge, stem cells are separated from the bone marrow
3. Implanted into spinal canal via lumbar puncture- a simple procedure

As easy as 1,2, 3!

Improvements in Lauren After Stem Cell Treatment

• Can sleep through the night for the first time
• Less Frustrated
• Better focused, more compliant
• Moms says a “40% general improvement which is huge for an autistic child”

From the stem cell article:

Now, more than five months since her treatment, Mrs. DiCorcia reports that her daughter is still doing well, “Lauren is doing well. I would have to say that she ‘plateaued’ at about the 12-week mark. Her situation is stable and fortunately all positive effects have persisted. I wish the doctor could fly to the US and perform the therapy here!”

I wish they could perform the procedure here too Mrs. DiCorcia.   Again, nobody is saying the stem cell therapy has cured Lauren.  But the improvement in the quality of life is what is most important.  And Lauren’s mom says the improvement was 40%- in a simple procedure.

Now, Lauren had nothing to lose, the research has been done-  the procedure used her own Adult Stem Cells so was perfectly safe.   And it paid off for the family.

Here is the full letter from Lauren’s mother addressed to Obama-

Dear President Obama,

I am the mother of a 10-year-old autistic daughter. In January, we took Lauren to Cologne, Germany for Adult Stem Cell therapy. The center used her own stem cells drawn from her hip bone marrow, centrifuged the next day, and then reinserted via lumbar puncture the following day (2.95 million cells). Both procedures were quick and not invasive at all. In the past 6 weeks we have seen significant improvements in our daughter’s behaviors, focus, hyperactivity, and insomnia. I would rate a general improvement of about 40% – this is HUGE for a family living with autism. Our daughter started sleeping through the night for the first time (yes, she is 10 and got up every night) since stem cells. Lauren is happier just in her own skin – so much less frustrated and just generally happier. She is getting through her one-on-one therapy more quickly, better focused, and more compliant. Of course, it amazes me that this simple, non-controversial therapy cannot be done here in the United States.

Sincerely,
Judy DiCorcia

It amazes me too Judy.  You should send your letter to the FDA as well.

We have previously reported  on autism with Matthew Faiella who has also improved due to stem cell research after adult stem cell treatment in Costa Rica.  Here is more on Matthew and how stem cells have helped his autism

original post by Don Margolis

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.”

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