Following a recent apex court judgement, the National Medical Commission (NMC) has issued a strict advisory against the use of stem cell therapy for the treatment of Autism Spectrum Disorder (ASD).
The top medical body has said that the stem cell therapy should only be used in regular medical practice for diseases listed as “standard care” by the Ministry of Health and Family Welfare (MoHFW).
NMC said that if stem cell therapy is used for any condition outside the approved list, such as autism, it can only be done as part of an approved clinical trial.
If stem cells have undergone more than minimal manipulation, the research will be regulated by CDSCO. Whereas, if “stem cells have undergone less than minimal manipulation, research will be regulated by DHR, and in this case, in addition to the recommendations of the Institutional Ethics Committee (IEC) registered with DHR, the trials will have to be approved by the National Stem Cell Research Regulation Committee.”
Minimal manipulation of stem cells refers to processing techniques that preserve the cells’ original biological characteristics, structural integrity, and physiological functions. The levels of manipulation for stem cell therapy have been defined by CDSCO.
For trials, getting a written permission from the patients is a must. They shall apply no cost on the patient, and shall provide compensation in case of injury or death. The advisory makes it clear that any stem cell treatment offered outside these rules will be considered illegal. Clinics or practitioners offering unapproved therapies could face regulatory and legal action.
What is stem cell therapy?
Also called regenerative medicine, stem cell therapy has often been promoted as a “miracle cure” for a wide range of conditions. The treatment uses specialised human cells to repair, replace, or regenerate damaged tissues, organs, and cells.
This therapy treats conditions like blood cancers (via bone marrow transplants) and is being researched for Parkinson’s, diabetes, and heart disease. Doctors extract stem cells (from the patient's own fat/bone marrow or a donor), process them, and inject or infuse them into the damaged area to initiate repair and reduce inflammation. However, at present, only hematopoietic stem cell transplantation (HSCT), a type of stem cell therapy mainly used for blood-related conditions, is approved as standard care.
HSCT is currently permitted for several serious diseases, including:
Blood cancers like leukemia and lymphoma
Bone marrow disorders such as aplastic anemia
Conditions like multiple myeloma and myelofibrosis
Certain autoimmune diseases like multiple sclerosis and systemic sclerosis
For children, approved uses also include:
Thalassemia and sickle cell disease
Primary immunodeficiency disorders
Some childhood cancers like neuroblastoma and Ewing’s sarcoma
More importantly, mesenchymal stem cell therapy, a regenerative and immune-modulating treatment using adult stem cells derived from tissues like bone marrow, fat, or umbilical cord, is not approved for any diseases.
Nationwide advisory issued
As stem cell therapy is not widely regulated in India, many private labs have been minting money over the promise of treatment for autism. So, the medical councils and institutions across India have been asked to circulate these guidelines widely among doctors, hospitals, and medical colleges to ensure strict compliance.