Adult Stem Cell Trial to Treat Patients Up to 19 Days After Stroke Occurs

By David Prentice

Dr. Sean Savitz

Researchers at the University of Texas Health Science Center in Houston have enrolled their first patient in a trial to use adult stem cells to treat stroke up to 19 days after the stroke occurs. If successful it would greatly increase the number of stroke victims who might benefit from this innovative adult stem therapy.  Stroke is a leading cause of disability and death in the United States.

The patient suffered his stroke May 23 and was treated June 8 at Memorial Hermann-Texas Medical Center by Dr. Sean Savitz of the UT Medical School. Dr. Savitz is one of the investigators in the FDA-approved Phase II study. The study will investigate use of ALD-401, a therapy developed by the company Aldagen that uses a patient’s own bone marrow adult stem cells.  Studies found that these cells enhance recovery after stroke in mice. The trial is a double-blind study, meaning that neither the patients nor the doctors know which patients receive the actual treatment, to prevent any bias in interpreting the results.

According to Dr. Savitz:

“This represents a new approach using stem cells for stroke. A major question in the field of stem cell research is whether we can extend the time window for administering stem cells. A longer window increases the number of patients that might be helped.”

Dr. Savitz is also currently involved in another trial that treats stroke patients with their own adult stem cells. In these trials the cells are injected within the first 3 days after the stroke. Early results from his first patient are very encouraging.

As noted here  Roland Henrich was originally admitted to the emergency room at Memorial Hermann-Texas Medical Center on March 25, 2009, with signs of stroke–he could not speak and had significant weakness on his right side. Because it was beyond the few hours window for use of the clot-dissolving drug TPA, the adult stem cell trial was his only option. The next day some of his bone marrow was removed, the adult stem cells separated, and returned intravenously to the patient. In less than a week doctors noted that he was recovering remarkably well and had not shown any signs of paralysis. Within 11 days of the treatment Mr. Henrich was walking, climbing stairs unassisted, and said his first word after the stroke, captured on a local news video and surprising his own doctor and leader of the clinical trial. Other studies have indicated that adult stem cells can have a positive effect long after the stroke occurs.

And as discussed here last week, doctors at Northwestern University have already shown that adult stem cells can relieve angina pain in heart patients.

About 850,000 U.S. heart patients have angina–chest pain caused by blocked coronary arteries–that persists despite available treatments. The study examined 167 patients with refractory angina; patients received either a low or high dose of their own adult stem cells injected into their damaged heart muscle, or a placebo injection. The results, published in the journal Circulation Research, showed that patients who received their adult stem cells experienced significant improvements in angina frequency and exercise tolerance.

In smaller previous studies reported in 2010, scientists in Florida and Brazil had found that adult stem cells injected directly into the heart could relieve angina in patients, and a Spanish group had also shown some improvement in angina patients’ symptoms.

Previous research has also show the ability of adult stem cells to shrink enlarged hearts and also long-term evidence that adult stem cells can treat chronic heart failure.

Dr. Prentice is Senior Fellow for Life Sciences, Family Research Council.

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