Journal
STEM CELLS TRANSLATIONAL MEDICINE
Volume 3, Issue 12, Pages 1398-1401Publisher
WILEY
DOI: 10.5966/sctm.2014-0147
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Funding
- Clinical Translational Science Award (SPECTRUM) [NIH 2U54TR000123]
- Stanford Institute for Stem Cell Biology and Regenerative Medicine
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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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