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National Guidelines for Stem Cell Research and Therapy
Mar 28, 2015

Stem Cells are unique in many ways. The two basic characteristics of pluripotent stem cells are their capacity for self-renewal and multi lineage differentiation. They may survive indefinitely and differentiate unpredictably when introduced into the human host. They may also give rise to tumors such as teratomas.

 

National Guidelines

  • The guidelines prohibit stem cell therapy and consider its use for any other purpose outside the domain of clinical trial unethical in the country. 

  • As per the National Guidelines for Stem Cell Research (2013), at present, there are no approved indications for stem cell therapy other than the Hematopoietic Stem Cell Transplantation (HSCT) for hematological disorders. 

  • Accordingly, all stem cell therapy other than the above shall be treated as investigational and conducted only in the form of a clinical trial after obtaining necessary regulatory approvals. 

  • Use of stem cells for any other purpose outside the domain of clinical trials will be considered unethical and hence is not permissible.

  • As per the guidelines, an additional layer of oversight, besides the Institutional Ethics Committee (IEC), in the form of Institutional Committee for stem cell research (IC-SCR) and National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) has been introduced to review and monitor stem cell research at the institutional as well as National level. 

  • National apex committee for stem cell research and therapy will monitor and oversee activities at national level and institutional Committee for stem cell research at institutional level. 

  • These oversight committees shall ensure that review, approval and monitoring of all research projects in the field of stem cell research are done rigorously and effectively as per the National Guidelines. 

  • This mechanism of additional review has been accepted by the scientific community in the country and the NAC-SCRT has become operational. 

  • Till date, 82 organizations/Institutes across the country have applied for registration of their IC-SCRs with NAC-SCRT, out of which only 5 institutes have fulfilled the criteria and have been granted registration. 


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