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Participants Needed to Test Stem Cell Therapy for Stroke

Millions of stem cells derived from the bone marrow of healthy adult donors have been implanted in the brains of two stroke survivors at UPMC, one of two sites conducting a safety and dose escalation study of the technique.
Led locally by Douglas Kondziolka, M.D., Peter J. Jannetta Professor and vice-chairman, Department of Neurological Surgery, and Lawrence Wechsler, M.D., professor and chair, Department of Neurology, University of Pittsburgh School of Medicine, the trial is the first step in determining whether bone marrow stem cells injected into the brain have therapeutic value in the healing of stroke lesions.
Funded by Mountain View, Calif.-based SanBio, Inc., the project will evaluate stroke therapy using SB623 cells, which are stem cells that are isolated from bone marrow and modified using recombinant DNA methods. The other testing site is at Stanford University.
“Lab and animal testing of these cells have shown that they are not replacing the neurons that have been lost,” explained Dr. Kondziolka. “Eventually, the transplanted cells disappear. But while they’re present, they appear to secrete factors that encourage the brain to repair itself by rebuilding neural connections or helping existing ones work better.”
The researchers are seeking participants between the ages of 18 and 75 who have had an ischemic stroke between six months and three years before study entry. Ischemic strokes occur when a blocked artery interrupts the flow of blood and oxygen in the brain, leading to cell death. Study candidates will undergo brain scans and be evaluated to ensure they have plateaued in their recovery from the stroke.
Participants receive local anesthetic and light sedation for the surgical procedure, Dr. Kondziolka said. Small incisions are made in the scalp and skull and, using scans and brain mapping technology, a probe is guided to the stroke area for deposition of the SB623 cells. Participants will be evaluated periodically for the next two years.
The first six patients received 2.5 million cells; the next six will receive 5 million cells; and the final six, 10 million cells, Dr. Wechsler said. Between each dose escalation, the participants will be carefully monitored to verify the process is safe.
He noted that every year, 800,000 Americans have strokes, making it the fourth leading cause of death and the leading cause of adult disability. Even small changes in neurological function can lead to a big effect on function.
“A little gain in leg strength could mean the difference between requiring a wheelchair and walking. The ability to grip could mean being able to feed yourself,” Dr. Wechsler said. “Cell therapy for stroke and other neurological disorders holds great promise, but first we must methodically test these techniques to ensure safety before we can determine their effectiveness.”
For more information on the SanBio study, contact study coordinator Julia Billigen at 412-605-3959 or BilligenJB@upmc.edu.

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