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The Challenges of First-in-Human Stem Cell Clinical Trials: What Does This Mean for Ethics and Institutional Review

Roger A Barker1, Melissa K Carpenter2, Stuart Forbes3

  • 1Cambridge University, Cambridge Centre for Brain Repair, E.D. Adrian Building, Cambridge CB2 2PY, UK.

Stem Cell Reports
|May 10, 2018
PubMed

Insights

The International Society for Stem Cell Research (ISSCR) created practical questions to guide the approval of stem cell therapies. This ensures patient safety and evidence-based efficacy for clinical trials.

Area of Science:

  • Regenerative Medicine
  • Translational Science
  • Biomedical Ethics

Background:

  • Stem cell interventions are progressing toward clinical trials, necessitating rigorous evaluation.
  • Unproven stem cell therapies create confusion and potential patient risk.
  • Existing review processes may lack specialized stem cell biology expertise.

Purpose of the Study:

  • To address the need for comprehensive review of early-stage stem cell trials.
  • To supplement ethics and institutional review boards' assessments.
  • To ensure patient safety and scientifically sound stem cell interventions.

Main Methods:

  • Development of a set of practical questions by the International Society for Stem Cell Research (ISSCR).
  • Focus on evidence-based answers for preclinical efficacy and scientific rationale.
  • Guidance for the approval process of stem cell-based trials.

Main Results:

  • A structured framework for evaluating stem cell trial applications.
  • Identification of key questions for assessing scientific validity and safety.
  • Support for informed decision-making by review boards.

Conclusions:

  • Standardized questions are crucial for the responsible advancement of stem cell therapies.
  • Ensuring preclinical evidence and safety is paramount before human trials.
  • ISSCR guidelines aim to foster trust and rigor in stem cell research.
Keywords:
early phase clinical trialsguidelineshuman stem cell-derived interventionsinstitutional review and ethics boardsreview process

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