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 prohibited several areas of research in stem cell including research related to human germ line gene therapy and reproductive cloning.
As per the new guidelines, in the current state of scientific knowledge and understanding, stem cell research in several areas stands prohibited. They included research related to human germ line gene therapy and reproductive cloning; in vitro culture of intact human embryos, regardless of the method of their derivation, beyond 14 days of fertilization or formation of primitive streak, whichever is earlier; clinical trials involving transfer of xenogeneic cells into a human host; any clinical research on Xenogeneic-Human hybrids; use of genome modified human embryos, germ-line stem cells or gametes for developmental propagation; research involving implantation of human embryos (generated by any means) after in vitro manipulation, at any stage of development, into uterus in humans or primates; and breeding of animals in which any type of human stem cells have been introduced at any stage of development, and are likely to contribute to chimeric gonadal cells.
The ICMR and the DBT released the new revised draft National Guidelines for Stem Cell Research, 2017 after incorporating recent advances stem cell research in the country. Earlier, the ICMR and the DBT had framed the Guidelines for Stem Cell Research and Therapy in the year 2007. The National Apex Committee for Stem Cell Research (NAC-SCRT) and drafting committee has been updating these guidelines from time to time based on new knowledge generated in the field. These guidelines were further revised in 2013 as National Guidelines for Stem Cell Research (NGSCR).
The framing and updating of these guidelines are of utmost importance as in recent years, stem cell biology has emerged as an important area of biomedical research with potential applications in developmental biology, disease modelling, tissue engineering, drug development, toxicity testing and others. Use of stem cells in regenerative medicine holds promise for improving human health by restoring the function of cells and tissues damaged due to degeneration and/or injury. Like all other medical innovations, emerging research on stem cells and translational biology not only requires a sound scientific rationale, but also strict adherence to ethical, legal and social issues. Apart from challenges of selecting appropriate stem cells for a particular condition, there are important concerns related to the use of embryos for creating human embryonic stem cell (hESC) lines as these may lead to commoditization of human cells and tissues.
Further, there is an inherent risk of exploitation of individuals particularly those belonging to the underprivileged groups. Besides, there are challenges related to the contentious issue of human germ-line engineering and reproductive cloning.
The National Guidelines for Stem Cell Research (NGSCR)-2017 takes into consideration all these issues, including recent developments in germ-line modification/editing. The guidelines take note of the fact that pluripotent stem cells derived from a variety of sources are now easily accessible for clinical trials, often without rationale and hence suitable procedures for their use and handling are required.