Wrongful Termination: Lessons From the Geron Clinical Trial
Ethics
Male
0301 basic medicine
Clinical Trials as Topic
0303 health sciences
03 medical and health sciences
Humans
Female
Embryonic Stem Cells
Spinal Cord Injuries
Stem Cell Transplantation
3. Good health
DOI:
10.5966/sctm.2014-0147
Publication Date:
2014-10-09T06:57:09Z
AUTHORS (2)
ABSTRACT
Summary
Geron Corporation is a publically traded company that launched a phase I clinical trial of a human embryonic stem cell-based therapy for spinal cord injury. The company enrolled the first patient in October 2010 and stopped the trial 1 year later. The fifth patient had been enrolled but not transplanted when the company announced the trial's end. After discussions with clinical staff and family, an agreement was reached to add her to the cohort and proceed with the transplant. Two and half years later, the research is still waiting to restart. With this background in mind, we discuss the major ethical and social questions raised by the Geron case. We offer recommendations for institutional review boards and clinical sites as they deliberate approvals of early-phase trials in frontier medicine.
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