New Delhi, Oct. 11: The Centre today released updated national guidelines on stem cell research to curb what health officials say is the "indiscriminate use of stem cells" for medical disorders without evidence of efficacy or safety of therapies offered to patients.
The guidelines, revised after about a decade, approve the therapeutic use of stem cells - progenitor cells that have the capacity to turn into diverse types of cells in the body - for only limited sets of diseases, mainly blood disorders and some cancers.
The document, prepared by the Department of Biotechnology and the Indian Council of Medical Research, cautions that all other medical applications of stem cells should be viewed as clinical research and doctors should not offer such applications as commercial therapies.
"This guidance is intended for doctors and patients - some doctors need to understand what they can do and what they should not do, and patients need to know that some claims are not backed by evidence," said Geeta Jotwani, a senior scientist and deputy director-general at the ICMR, told The Telegraph.
The guidelines follow long-standing concerns that some doctors in the private sector offer commercial stem cell therapies for diverse disorders - such as arthritis, cardiovascular diseases, diabetes, kidney disorders, liver cirrhosis, Parkinson's disease and stroke - without adequate evidence of efficacy or safety. "Such clinics prey upon patients' desperation," said one health official.
The websites of such clinics list a number of diseases for which they claim stem cell therapies have shown to help and cite "testimonials" from patients they claim they have helped. Health officials say costs of treatment start from tens of thousands to lakhs of rupees.
The guidelines have been revised to ensure that while there is encouragement for stem cell research, this does not in any way compromise the safety of patients and vulnerable individuals, the ICMR and the DBT said today in a statement<> explaining the significance of the revision.
In typical stem cell therapy protocols, doctors isolate stem cells from the marrow or other sources and inject them in the hope that the cells differentiate into the desired cell type and help the body regain lost functions.
But the new guidelines specify a limited number of health disorders - mainly leukaemia, lymphomas, some solid tumours and other blood disorders - for which stem cell therapy is "approved".
Any use of stem cells in patients other than for these approved disorders is "investigational at present" and must be done only as "an approved and monitored clinical trial to advance science and medicine and not as therapy," the ICMR-DBT statement said.
Clinical trials are intended to establish the safety and efficacy of experimental therapies. Doctors who wish to pursue clinical trials of stem cells for specific unapproved disorders would need to register with the ICMR and follow standard protocols that such trials require, Jotwani said.
Health officials are also hoping patients and their caregivers could use the list of approved disorders in the guidelines - available on the ICMR website - to determine what treatment is proven therapy and what is still experimental and unproven.
Neither the ICMR nor the DBT has any regulatory authority and, senior ICMR officials say, it would be up to the Medical Council of India or drug regulators to take action against doctors who defy the guidelines and continue to offer unproven stem cell therapies.