Target populations for first-in-human embryonic stem cell research in spinal cord injury

Cell Stem Cell. 2011 May 6;8(5):468-75. doi: 10.1016/j.stem.2011.04.012.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biotechnology / ethics
  • Biotechnology / trends
  • Clinical Trials, Phase I as Topic
  • Cost-Benefit Analysis
  • Embryonic Stem Cells / transplantation*
  • Humans
  • Multiple Sclerosis / epidemiology
  • Multiple Sclerosis / therapy*
  • Patient Rights
  • Patient Selection / ethics*
  • Risk Adjustment
  • Spinal Cord Injuries / economics
  • Spinal Cord Injuries / epidemiology
  • Spinal Cord Injuries / therapy*
  • Stem Cell Research*
  • Stem Cell Transplantation*