Wrongful Termination: Lessons From the Geron Clinical Trial

• DOI: 10.5966/sctm.2014-0147
• Publication Date: 2014-10-09T06:57:09Z
• Authors: Christopher Thoma...; David Magnus
• Keywords: 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

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.