The National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) has determined that given the current state of knowledge and evidence, only haematopoietic stem cell transplants for blood diseases and limbal stem cell transplants for corneal diseases can be performed as standard therapy outside of clinical trials in India.
An announcement to this effect by the NAC, constituted by the union health ministry early last year for effectively reviewing and monitoring the stem cell research in the country, comes in the wake of widespread complaints from different quarters that unscrupulous elements in the medical fraternity are be-fooling the gullible patients by offering assured treatment involving stem cells for unapproved therapies like kidney transplantation, cerebral palsy, etc.
At present, stem cell therapy is approved for diseases like bone marrow transplantation and haematopoietic stem cell transplants for blood diseases and limbal stem cell transplants for corneal diseases. Any use of stem cells for diseases other than these are not approved in the country.
All other forms of stem cell transplants, including those with blood or marrow derived stem cells, cord blood stem cells, mesenchymal stem cells and any embryonic stem cell derived tissue should only be used within an appropriately reviewed and monitored clinical trial that has been registered on the Indian Council of Medical Research (ICMR) clinical registry and in accordance with current national guidelines, a senior scientist associated with the NAC said.
Meanwhile, the 12-member NAC, headed by Dr Alok Srivastava, haematologist, Christian Medical College (CMC), Vellore, is revising the Guidelines for stem cell research regulation in the country.
Once the union health ministry finalises the revised guidelines for stem cell research regulation, all institutions involved in any type of stem cell research and therapy should be registered with the NAC. All the IC-SCRT have to submit annual reports to NAC. A regular monitoring will be done by the NAC by obtaining periodic report from all centres and site visits as and when required to ensure adherence to standards.
It will have the responsibility to examine the scientific, technical, ethical, legal and social issues in the area of stem cell based research and therapy. It will approve, monitor and oversee research in the restricted areas. Every scientific proposal using ES cells under restrictive category has to be cleared through IC-SCRT/IEC before referring to NAC-SCRT.