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June 2017

Challenges to Translation and the Hippocratic Oath by Premature Termination of Spinal Cord Stem Cell–Based Trials

Author Affiliations
  • 1Spinal Cord Injury Center, Balgrist University Hospital, Zurich, Switzerland
  • 2Wings for Life Spinal Cord Research Foundation, Salzburg, Austria
  • 3Department of Neurological Surgery and the Miami Project to Cure Paralysis, University of Miami/Miller School of Medicine, Miami, Florida
  • 4Spinal Cord Injury Division, Neurological Institute, the Ohio State University, Columbus
JAMA Neurol. 2017;74(6):635-636. doi:10.1001/jamaneurol.2017.0318

Untimely termination of clinical trials owing to strategic corporate considerations (30%)1 or futility analysis (50%)1 account for most prematurely discontinued studies, and spinal cord injury (SCI) trials are no exception (Figure).2 In this commentary, we advocate for clear termination rules, including an orderly exit plan, as a prerequisite for regulatory approval to optimize safe and effective clinical translation. Invasive cell transplant trials in SCI require excellent preclinical and clinical safety and efficacy data, pioneering spirit, and intensive resource investment. However, premature termination without an orderly exit plan produces harmful consequences worthy of discussion.

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