Guidelines for neural repair studies in humans

December 21, 2001

TAMPA, Fla (Dec. 21, 2001) -- Promoting ethical and rigorous research on investigational treatments for brain repair is the focus of new recommendations published by the American Society for Neural Transplantation and Repair (ASNTR).

The "Considerations and Guidelines for Studies of Human Subjects" will be published Dec. 24 in the journal Cell Transplantation. Lead authors were Eugene Redmond Jr., MD, chair of the ASNTR Practice Committee and director of Neural Transplantation and Repair at Yale University, and Thomas Freeman, MD, co-chair of the Practice Committee and director of the Neural Reconstruction Program at the University of South Florida and Tampa General Hospital.

The guidelines were endorsed by the society's full membership, which includes most of the world's researchers working on applications of fetal tissue, stem cells and gene therapy for brain repair.

"Inadequate preliminary data or study design flaws have sometimes set the field back -- we hope these guidelines help investigators 'get it right' the first time," said Dr. Redmond.

"Clinicians are beginning to have the capability to modify the nervous system through cell therapy, transplants, gene therapy and the advancing developments of stem cell therapies," Dr. Freeman said. "Our goal is to make sure these new treatments are developed in a scientifically rigorous fashion and in a manner as safe as possible for patients."

The explosion of neuroscience research in recent years has led to the growth of novel, investigational cell and gene replacement therapies for Alzheimer's disease, Parkinson's disease, stroke and other brain disorders. At the same time, researchers have been criticized by other scientists and the public who argue that some therapies put patients at disproportionate risk because they have been rushed to clinical trials without sufficient preclinical findings of safety and effectiveness.

The ASNTR recommendations support existing federal regulations while addressing new concerns associated with neural transplantation and repair, including:

University of South Florida (USF Health)

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