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

• Published in: Cell stem cell Vol. 8; no. 5; pp. 468 - 475
• Main Authors: Bretzner, Frédéric, Gilbert, Frédéric, Baylis, Françoise, Brownstone, Robert M.
• Format: Journal Article
• Language: English
• Published: Cambridge, MA Elsevier Inc 06.05.2011; Cell Press
• Subjects: Biological and medical sciences; Biotechnology - ethics; Biotechnology - trends; Cell differentiation, maturation, development, hematopoiesis; Cell physiology; Cerebrospinal fluid. Meninges. Spinal cord; clinical trials; Clinical Trials, Phase I as Topic; Cost-Benefit Analysis; embryonic stem cells; Embryonic Stem Cells - transplantation; ethics; Fundamental and applied biological sciences. Psychology; Geron; Humans; Medical sciences; Molecular and cellular biology; Multiple Sclerosis - epidemiology; Multiple Sclerosis - therapy; Nervous system (semeiology, syndromes); Neurology; Patient Rights; Patient Selection - ethics; patients; Risk Adjustment; sclerosis; spinal cord; Spinal Cord Injuries - economics; Spinal Cord Injuries - epidemiology; Spinal Cord Injuries - therapy; spinal diseases; Stem Cell Research; Stem Cell Transplantation; Human; Nervous system diseases; Embryonic cell; Stem cell; Spinal cord trauma; Central nervous system disease; Spinal cord disease
• ISSN: 1934-5909; 1875-9777; 1875-9777
• DOI: 10.1016/j.stem.2011.04.012

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.