Revised draft norms for stem cell research marks many restrictive areas – pharmabiz.com

The revised draft National Guidelines for Stem Cell Research, 2017, released recently by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT), has earmarked several restrictive areas of research in stem cell such as creation of human pre-implantation embryos by IVF, ICSI, SCNT or any other method with the specific aim of deriving ESC lines for any purpose.

The guidelines state that such research needs close supervision and strict adherence to the guidelines. The investigator needs to provide reasoning taking into consideration that the proposed research cannot be carried out with existing ESC lines, or those that can be derived from spare embryos; minimum number of embryos/blastocysts required for such research must be clearly defined; research teams involved should have appropriate expertise and requisite training in derivation, characterization and culture of ESCs.

As per the revised guidelines, clinical trials using any type of stem cells (progenitor or differentiated) after major manipulation shall require prior approval of the CDSCO after obtaining approval from IC-SCR and IEC. Clinical trials sponsored by multinationals, employing cell products developed outside India, will also need prior approval from CDSCO following clearance from both IC-SCR and IEC. All international collaborations require approvals from the respective funding agencies followed by approval from the Health Ministrys Screening Committee as per Government of India Guidelines. Import of any type of stem cells and/or their products requires license from CDSCO as per the established regulations.

Research involving introduction of human ESC/iPSC/SSCs into animals (including primates), at embryonic or fetal stages of development for studies designed to understand the patterns of differentiation and integration of human cells into non-human animal tissues shall conform to several norms. They include if the expected outcome of the study is suggestive of a possibility that human stem cells could contribute in a major way to the development of brain or gonads of the recipient animal, the scientific justification for such experiments must first be substantiated with data. Animals derived from such experiments shall not be allowed to breed. Such proposals would need approval of the NAC-SCRT for additional oversight and review after clearance has been granted by IC-SCR, IEC and IAEC (or CPCSEA).

Studies on chimeras where stem cells from two or more species are mixed together at any stage of early development (embryonic or fetal), for understanding patterns of development and differentiation would also require prior approval of NAC-SCRT after clearance has been granted by the IEC and IC-SCR. Genome modification including gene editing (for example by CRISPR-Cas9 technology) of stem cells, germ-line stem cells or gamete and human embryos is restricted only to in vitro studies. It will require thorough review by the IC-SCR, IEC and IBSC and finally by RCGM. Research teams involved should have appropriate expertise, requisite training and infrastructure in gene editing/genome modification and characterization. The source of somatic cells and/or minimum number of embryos, germ line cells or gametes required for this research should be clearly defined. Only spare embryos, germ-line cells or gametes should be used. Genome modified human embryos should not be cultured beyond 14 days of fertilization or formation of primitive streak, whichever is earlier.

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Revised draft norms for stem cell research marks many restrictive areas - pharmabiz.com