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National Guidelines for Stem Cell Research
Mar 03, 2014

Indian Council of Medical Research and Department of Biotechnology jointly released guidelines in 2007 for Stem Cell Research and Therapy. Considering the developments in the field and the views of the stake holders, the 2007 guidelines were revised and finalized recently and named as National Guidelines for Stem Cell Research. The salient features of the National Guidelines for Stem Cell Research (2013) are as follows:

  • National Guidelines for Stem Cell Therapy-2013 reiterate that the general principles of biomedical research involving human participants shall also be applicable to all human stem cell research.
  • The guidelines have been laid down to ensure that research with human stem cells is conducted in a responsible and ethical manner and complies with all regulatory requirements pertaining to biomedical research in general and of stem cell research in particular.
  • Updated guidelines have incorporated advances in the field with regards to induced pluripotent stem cells (iPSCs), xeno-free cultures, characterising cell product for therapy and to harmonize them with the internationally revised guidelines.
  • One major recommendation has been to omit the word Therapy from the Title of the Guidelines. This has been done to emphasize the fact that stem cells are still not a part of standard of care; hence there can be no guidelines for therapy until efficacy is proven.
  • These guidelines are intended to cover only stem cell research, both basic and translational, and not therapy. It has been made clear in these Guidelines that any stem cell use in patients, other than that for hematopoietic stem cell reconstitution for approved indications, is investigational at present. Accordingly, any stem cell use in patients must only be done within the purview of an approved and monitored clinical trial with the intent to advance science and medicine, and not offering it as therapy. In accordance with this stringent definition, every use of stem cells in patients outside an approved clinical trial shall be considered as malpractice. It is hoped that this clear definition will serve to curb the malpractice of stem cell therapy being offered as a new tool for treating incurable diseases.
  • These Guidelines apply to all stakeholders including individual researchers, organizations, sponsors, oversight/regulatory committees and any others associated with both basic and clinical research on all types of human stem cells and their derivatives.

National Guidelines for Stem Cell Research envisage setting up of a National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) to monitor and oversee activities at national level and Institutional Committee for Stem Cell Research (IC-SCR) at institutional level. These Committees shall ensure that review, approval and monitoring of the research projects in the field of Stem Cell Research are done rigorously and effectively as per the national guidelines.

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