ICMR seeks end to indiscriminate use of stem cell for medical disorders
18 October 2017
The Indian Council of Medical Research (ICMR) today released updated national guidelines on stem cell research, in what health authorities said, to curb the "indiscriminate use of stem cells" for medical disorders without evidence of efficacy or safety of therapies offered to patients.
The Council also proposed to bar commercial banking of stem cells derived from biological materials such as cord tissue, placenta, tooth extract and menstrual blood.
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 some 30-odd diseases, mainly blood disorders and cancers.
ICMR said these guidelines do not apply to use of hematopoietic stem cells for treatment of various haematological, immunological and metabolic disorders since these have already been established as a standard of medical care.
Protein rich plasma (PRP) and autologous chondrocyte/oteocytes implantation does not fall under the purview of these guidelines as they are categorised as other cell based applications and not stem cell transplantation.
The apex medical research agency listed 20 types of indications (diseases) for adults and another 13 categories of indications for children below 18 years, where stem cell treatment are permitted. Besides cancers, some complicated congenital diseases are also on the list.
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 concerns that some doctors in the private sector offer commercial stem cell therapies for diverse disorders, including arthritis, cardiovascular diseases, diabetes, kidney disorders, liver cirrhosis, Parkinson's disease and stroke, without adequate evidence of efficacy or safety.
These clinics also list the diseases for which they claim stem cell therapies have shown to help and cite "testimonials" from patients. The costs of such treatment start from tens of thousands to lakhs of rupees.
Also, the guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development