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Logo for the Journal of Rehab R&D
Vol. 40 No. 4, July/August 2003, Supplement
Pages 71 — 80

Cellular therapies for spinal cord injury: What will the FDA need to approve moving from the laboratory to the human?
Jacqueline Sagen, PhD
The Miami Project to Cure Paralysis, University of Miami School of Medicine, Miami, FL
Abstract — The transplantation of living cells and tissues to restore function and/or provide therapeutic molecules has been an active and ongoing area of research interest for over 25 years. Several of these potential therapies have reached initial clinical trials, and it is likely that applications will continue to expand, and that novel and improved approaches will be explored over the next several years. In the past, many of these experimental approaches were tested in early clinical trials without the oversight of regulatory agencies such as the Food and Drug Administration. However, as novel cellular therapies move from preclinical laboratory findings to the clinical arena, researchers and regulators face new and continually evolving issues and uncertainties involving long-term safety and efficacy. Using adrenal medullary transplantation in the spinal cord for pain as an example, this review presents an overview of past and current regulatory guidelines for moving these promising, novel cellular transplantation therapies from the laboratory to the human.
Key words: cell transplantation, Center for Biologics Evaluation and Research (CBER), chromaffin cells, Food and Drug Administration (FDA), pain, spinal cord injury, regulatory agencies.
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