Proposed way of alternative way of generating data from stem cells interventions performed under 21 CFR part 1271 (CGTP) 

In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.        

(The Helsinki Declaration, Article 37)

Stem cells have characteristics that distinguish them from drugs, biologics, or medical devices. Considerable body of science has not yet been accumulated to develop and deliver safe and effective treatments. Their regulation remains unclear.

Minimal manipulation: 

  • (1) For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement
  • (2) For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues.

SlideShare Issuu

Read more: