After more than two years of discussions and debate, the Indian Council of Medical Research (ICMR) has finalised the much-awaited 'Guidelines for Stem Cell Research' and will eventually be issued in a day or two. The much-discussed final document will provide ethical and scientific directions to scientists and clinicians working in the field of stem cell research in the country.

Senior ICMR officials who were burning the proverbial midnight oil to finalise the Guidelines said that the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT), constituted by the health ministry in March 2011, has already finalised the guidelines and the final document will be released any day now. The health ministry constituted the NAC, under the chairmanship of Dr Alok Srivastava, haematologist, Christian Medical College (CMC), Vellore, for effectively reviewing and monitoring the stem cell research in the country.

Earlier, the ICMR and the Department of Biotechnology (DBT) had jointly formulated a draft Guidelines for Stem Cell Research and Therapy in the year 2007, prescribing strict procedures for sourcing and the use of stem cells by research institutions. After its constitution, the NAC felt the need for reviewing and revising the guidelines as the committee felt that several developments had occurred during the long period since the ICMR issued the draft guidelines.

After receiving several valuable suggestions and opinions from the stakeholders and experts on the draft guidelines, the NAC reviewed these suggestions and opinions to incorporate several valuable suggestions in the final document to make it a more acceptable and improved document.

According to experts, stem cell research holds great promise for improving human health by restoring cellular and organ function damaged by degeneration and various injuries. At the same time it also raises several scientific, ethical and social issues in the development of such applications. Apart from challenges of using the right kind of stem cells in the most appropriate way for a particular disease, there are also issues related to the use of human embryos to create human embryonic stem (hES) cell lines, potential for commoditization of human tissues and cells with inherent danger of exploitation of underprivileged people, and challenges related to prevention of human germ-line engineering and reproductive cloning.

There are also potential dangers of tumourigenicity with use of these cells keeping in view their potential for unlimited proliferation and possible introduction of genomic changes during in-vitro manipulations also limitations related to immunological tissue incompatibility between individuals. Research in this field, therefore, needs to be regulated with special attention to these issues.

Of utmost importance is assurance of safety and rights of those donating embryonic, fetal or adult stem cells for basic and clinical research. Safeguards have to be in place to protect research participants receiving stem cell transplants, and patients at large from receiving unproven stem cell therapies. In recent years societal concern regarding compensation for research related injury has also gained considerable momentum.

All these issues will be addressed by the final 'guidelines for stem cell research' which the ICMR is expected to be issued in a day or two.