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Wrongful termination: lessons from the Geron clinical trial

Christopher Thomas Scott1, David Magnus2

  • 1Center for Biomedical Ethics, Stanford University, Stanford, California, USA cscott@stanford.edu.

Stem Cells Translational Medicine
|October 10, 2014
PubMed

Insights

Geron Corporation

Area of Science:

  • Stem cell therapy research
  • Clinical trial ethics
  • Spinal cord injury treatment

Background:

  • Geron Corporation initiated a Phase I clinical trial for human embryonic stem cell therapy in spinal cord injury patients.
  • The trial was halted after one year, with one patient awaiting transplantation.

Purpose of the Study:

  • To discuss the ethical and social implications of the Geron Corporation's stem cell trial for spinal cord injury.
  • To provide recommendations for institutional review boards and clinical sites regarding early-phase frontier medicine trials.

Main Methods:

  • Case study analysis of the Geron Corporation's clinical trial.
  • Discussion of ethical and social issues arising from the trial's termination and subsequent events.

Main Results:

  • The Geron case highlights significant ethical and social challenges in early-phase stem cell therapy trials.
  • Delays in restarting the research underscore the complexities of navigating patient consent and regulatory oversight.

Conclusions:

  • The Geron case offers critical lessons for the ethical conduct of frontier medicine research.
  • Recommendations are provided to guide institutional review boards and clinical sites in approving and managing novel therapeutic trials.

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