The expert committee in charge of framing national regulatory guidelines for stem cell therapy is to come out with the first draft of the guidelines within a month. The final meeting of the committee, held last week decided to invite comments from all stake holders on its draft before finalizing the regulatory norms, it is learnt.

According to informed sources, the guideline, meant to be converted into legislation at a later stage, will allow export of stem cells for research purposes. The guideline would also prescribe specific standards needed for a medical institution to carry out stem cell therapy. The move is to put an end to the questionable moves of several private institutions to perform stem cell therapy for various illnesses.

Expressing happiness over the development, leading medical institutions offering stem cell therapy said that the "ICMR" approval should become pre-requisite for stem cell therapy. The new guidelines would be the revised version of the existing stem cell guideline brought out by the ICMR. It should be noted that the Parliamentary Standing Committee on Health and Family Welfare had recommended expeditious drafting of the guidelines and formulation of the national policy in stem cell therapy. Expressing unhappiness with the delay in drafting the guidelines, the committee pointed out that the guidelines remained at the draft stage even after three years. The guidelines for helping regulation of stem cell research had been put on the Indian Council of Medical Research (ICMR) website in 2002 for consultation. The committee emphasised that the approval process of draft guidelines on the cases pending before the Drugs Controller-General of India should be accelerated in view of many clinics claiming good results in the treatment of incurable diseases through this therapy.

There are three sources identified for human stem cell collection - human embryos, umbilical chord blood and adult stem cells from bone marrow tissues and blood. The regulations were to prescribe strict procedures for stem cells sourcing from each of these sources.

There is also the need for specified procedures for stem cell transfusion to avoid all contentious issues that are likely to emerge while using stem cells for treatment of diseases like leukaemia, anaemia and other blood-born disorders. The existing regulations on blood transfusion were expected to be widened in scope for the disciplinary conduct of treatment involving stem cell transfusion. A guideline is to call for national committee to monitor the policy implementation. Each institution involved in stem cell research will be expected to establish an Institutional Committee for Stem Cell Research and Therapy.