Target Populations for First-In-Human Embryonic Stem Cell Research in Spinal Cord Injury

• DOI: 10.1016/j.stem.2011.04.012
• Publication Date: 2011-05-07T18:46:55Z
• Authors: Frédéric Bretzner; Frédéric Gilbert; Françoise Baylis; Robert M. Brownstone
• Keywords: 0301 basic medicine; Multiple Sclerosis; Clinical Trials, Phase I as Topic; Cost-Benefit Analysis; Patient Selection; Cell Biology; Stem Cell Research; 3. Good health; 03 medical and health sciences; Patient Rights; Genetics; Molecular Medicine; Humans; Risk Adjustment; Embryonic Stem Cells; Spinal Cord Injuries; Biotechnology; Stem Cell Transplantation

Geron recently announced that it had begun enrolling patients in the world's first-in-human clinical trial involving cells derived from human embryonic stem cells (hESCs). This trial raises important questions regarding the future of hESC-based therapies, especially in spinal cord injury (SCI) patients. We address some safety and efficacy concerns with this research, as well as the ethics of fair subject selection. We consider other populations that might be better for this research: chronic complete SCI patients for a safety trial, subacute incomplete SCI patients for an efficacy trial, and perhaps primary progressive multiple sclerosis (MS) patients for a combined safety and efficacy trial.