After a long wait, the guidelines for stem cell research are likely to come out very soon with the Indian Council of Medical Research (ICMR) is all set to submit the final recommendations to the Union health ministry before November 10.

``The guidelines are ready and we are going to submit the same formally to the government on November 8 or 9. The guidelines are all about the research infrastructure, how and when the therapy should be given to the patients and, about who would be responsible for managing the whole system,'' ICMR director general Prof N K Ganguly told Pharmabiz.

It may be noted that the need for a regulation in stem cell research arose in the wake of reports that some institutions in the country have jumped into stem cell research without having good manufacturing practices (GMP) and good tissue practices (GTP) approval from the authorities. Organizations such as Reliance Life Sciences, AIIMS, CCMB, TIFR and LVPEI are the early entrants to the stem cell research in the country.

Prof Ganguly said the stem cell research and its clinical applications would be promoted in the country in view of the vast scope for this new technology in modern therapeutic and biomedical research.

As part of the guidelines, there is also a plan to set up a national apex committee for mammalian cell based research and therapy for clearing stem cells from any source. The Committee would have the responsibility to examine the scientific, technical, ethical, legal and social issues in the area of cell based research and therapy.

The new technology is considered to be highly potential for therapy through regeneration of tissues or implantation of cell and tissues in nervous system diseases like Parkinson's disease, Alzheimer's, multiple sclerosis, spinal cord, cardiac infarction, bone and cartilage diseases, cancer and immune diseases and diabetes.

The guidelines are believed to have ample provisions to rein on the ethical, legal, and social issues by making mandatory the clearance through an institutional ethics committee and also adherence to the Ethical guidelines for Biomedical Research on Human Subjects" issued by the ICMR in October, 2000.

On umbilical cord blood stem cells, the proposed guidelines will have provisions to insure that no harm would occur to the foetus or the neonatal. There is a risk that the neonate donor may need his or her own cord blood later in life. If the blood has been used for another, he or she might be left without much needed blood, it is argued. Parents shall be informed of the risks of donation and a written consent would be obtained from them on behalf of the foetus, as per the new guidelines.