Supreme Court Questions Autism Stem Cell Trials

The Supreme Court is scrutinizing stem cell therapy for Autism Spectrum Disorder (ASD), demanding a comprehensive report on clinical trials from the Centre. The bench, comprising justices JB Pardiwala and R Mahadevan, has specifically asked the government to detail any applications received for such trials since its January ruling.

Furthermore, the court requires information on the measures being implemented to transition patients already receiving this controversial treatment into a regulated research framework. The Ministry of Health and Family Welfare has stated that stem cell therapy is not an approved routine treatment for autism, and the Indian Council of Medical Research (ICMR) permits it only for research purposes for specific conditions, excluding autism.

The United States' FDA also considers stem cell therapy experimental for conditions beyond blood stem transplantation for cancers and certain blood/immune disorders. The government has been directed to clarify in its compliance affidavit whether any applications for research or clinical trials involving stem cell therapy for ASD have been submitted to the competent regulatory authority, including the number, dates, and status of these applications.

Beyond governmental actions, the court has also directed the Parents Forum for Stem Cells in Autism and Cerebral Palsy, as well as institutions and clinics administering the therapy, to report on their efforts since the January judgment to bring ongoing treatments under a duly approved and regulated clinical trial framework. This includes informing the court if they have taken steps to comply with the established guidelines.