NEW DELHI: The Indian Council of Medical Research (ICMR)has appealed to doctors across the country to share scientific evidence on clinical efficacy of stem cells in any disease condition or disorder in their specialties. The appeal comes in the wake of several complaints by patients about the misuse of stem cell therapy.
The apex research body has also asked professional associations to submit a position statement on stem cell therapy in their area of specialty to help the public and professionals.
“Stem cell research is a very active area of research around the world. The current research focus is to understand the biology of stem cells and their potential clinical applications in a range of human diseases. However, as a proven therapy, stem cells are currently considered as a standard therapy option only in certain haematolymphoid and immunological conditions, as listed in the National Guidelines for Stem Cell Research (NGSCR-2017),” the ICMR said in its notice.
There is lack of clarity among patients and to some extent among the medical community in many countries including India about the disease indications where stem cell therapy is experimental and not an evidence-based therapy option, the research body observed. The issue is getting complicated with the increasing use of stem cells as a therapy for a wide range of medical conditions often with little or no scientific evidence of efficacy and with questionable means of promotion or misleading advertisements, it pointed out in the notice.
The ICMR has said that it and other government agencies have received several grievances of exploitation from patients and public organizations describing how they were lured into unproven stem cell therapies and wanted to know what action is being taken by the regulatory agencies and professional bodies.
The government has entrusted the ICMR to frame guidelines on stem cell therapy. The Guidelines for Hematopoetic (blood) Stem Cell Transplant are currently being drafted by ICMR. “For stem cell therapy in other non-haematological conditions the expert clinicians and representatives of professional societies are requested to provide the current status of evidence-based use of stem cell therapy in diseases that their specialty deals with, if any,” the ICMR said.
“Based on the feedback received by experts and professional societies and a detailed review of scientific literature Guidelines for Stem Cell Therapies shall be drafted, that may consider use of stem cell in a specific condition as one of the therapy options if there is level I or II scientific evidence and Grade A or B recommendation. To ascertain the level of evidence and grade of recommendation, the comprehensive and widely used Oxford Centre for Evidence-based Medicine— Levels of Evidence (March 2009) could be used,” it said.