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Stem cell therapy studies for stroke, cerebral palsy prepare for clinical trials
Date:1/29/2008

directly into the core, they do not survive in the area, which is devoid of a blood supply, Dr. Borlongan says. However the cells and their trophic factors can dramatically reduce the penumbra, the area of damaged cells surrounding the core, an area that can continue to grow several days after injury. Interestingly, these undifferentiated stem cells dont seem to interest the immune system, so immunosuppression is not required as it typically is for organ transplants, even when a human cell is placed in a rat, Dr. Borlongan says. Also, pilot studies that have followed rat models for two months after transplant a long time considering the average rat lives two years havent found any signs of tumor formation, which is a concern with stem cells. The new studies will follow transplants for six months, to ensure that efficacy and safety hold up, Dr. Borlongan says.

Theyll explore dose ranges between 400,000 and 40 million cells. We want to see, if we implant more cells, will it be more beneficial" says Dr. Borlongan. It may not be the more the merrier.

In preparation for clinical trials, the researchers already have clinical advisory groups for the studies and have begun submitting grant proposals and talking with the FDA. Smaller studies in non-human primate models may also be required before clinical trials begin, Dr. Borlongan says.


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Contact: Toni Baker
tbaker@mcg.edu
706-721-4421
Medical College of Georgia
Source:Eurekalert  

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