“Latest Stem Cells News”

After Barack Obama’s victory in the U.S. presidential elections, the economic community, in the middle of a recession and the worst financial crisis in the past decades, continues to hold its breath. The Democrat’s victory induce change and potentially more difficult times for the energy, pharmaceutical, telecommunications, and defense sectors, while the biotechnology and alternative energy sectors could be strengthened by the outcome of the elections. Obama has promised to increase investments in wind and solar energy and to spend 150 billion dollars in 10 years to hasten the development of hybrid automobiles and to increase the use of alternative energy on an “industrial scale”.

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Scientists may be growing impatient, but President Obama has been rightly taking his time in addressing a campaign promise to lift the ban on federal funding for research using new lines of stem cells to be taken from human embryos. Even for strong backers of embryonic stem cell research, the decision is no longer as self-evident as it was, because there is markedly diminished need for expanding these cell lines for either patient therapy or basic research. In fact, during the first six weeks of Obama’s term, several events reinforced the notion that embryonic stem cells, once thought to hold the cure for Alzheimer’s, Parkinson’s, and diabetes, are obsolete. The most sobering: a report from Israel published in PLoS Medicine in late February that shows embryonic stem cells injected into patients can cause disabling if not deadly tumors.

The report describes a young boy with a fatal neuromuscular disease called ataxia telangiectasia, who was treated with embryonic stem cells. Within four years, he developed headaches and was found to have multiple tumors in his brain and spinal cord that genetically matched the female embryos used in his therapy.

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In a couple of months, the first test to verify if embryonic stem cells directly injected inside patients’ brain plagued by stroke can regenerate damaged areas, will start in Scotland.
A team from Southern General Hospital of Glasgow selected 4 groups of 3 patients that will be treated during the next 2 years.
Firstly patients will take a dose of 2 millions embryonic stem cells. The amount will be gradually increased to 20 millions of stem cells, which is what doctors think patients need to start the re-creating processes.

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A new therapy based on embryonic stem cells will give a new hope to people who did lose their ability to move in some accident. But that’s not all, because this therapy, developed by the Geron Corp., is the demonstration that in USA, since a few days from Obama‘s election, a new course in research – above all in stem cells research – has begun.

The Food and Drug Administration (FDA) frees the medics to inject spinal stem cells extracted from embryonic tissue in legs paralysed patients since a short time. The treatment in on experimental phase, but stem cells should stimulate damaged nerves to grow.
The goal is to re-activate the spinal marrow normal functions. Unfortunately it’s not so operative for patients paralysed sinc more than 1 or 2 weeks.

Geron’s whole work is funded by private; at present no public funding are planned in this field due to Bush‘s 2006 veto, despite the United States Congress gives the go-ahead.
The fact that FDA did not oppose to this, although it’s an indipendent organization, suggests that something is changing.

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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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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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