Stem cell clinical trials for spinal cord injury: readiness, reluctance, redefinition

Stem Cell Rev Rep. 2011 Nov;7(4):997-1005. doi: 10.1007/s12015-011-9259-1.

Abstract

A wealth of scientific and clinical research has focused on the use of stem cells as a potential therapy for spinal cord injury (SCI), culminating most recently in the initiation of clinical trials. However, with the urgency that scientists and clinicians have undertaken to move forward with novel therapies for this devastating injury, the perspectives of stakeholders who live with a SCI have been left behind. Translational research in this rapidly growing field therefore overlooks a critically important viewpoint. We address this concern with a qualitative study of the perspectives on experimental stem cell treatments from individuals who have actually suffered a spinal cord injury. Using focus groups and interviews, we engaged individuals with thoracic and cervical SCIs at sub-acute and chronic stages post-injury. We found four major themes that inform the progression of stem cell research to clinical trials: 'readiness', 'the here and now', 'wait and see', and 'informed hope'. Taken together, the data suggest a profound difference related to target timing of stem cell clinical trials and the perspectives about timing from those who are the end-beneficiaries of therapy. To bridge this gap, we conclude with a number of considerations for the timing disparity of trials and recommendations for improving informed consent.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Clinical Trials as Topic / methods*
  • Cohort Studies
  • Female
  • Focus Groups
  • Health Knowledge, Attitudes, Practice
  • Humans
  • Informed Consent / standards*
  • Male
  • Mental Competency
  • Middle Aged
  • Spinal Cord Injuries / therapy*
  • Stem Cell Research
  • Stem Cell Transplantation / ethics*
  • Time Factors
  • Young Adult