Doctors Welcome Supreme Court Ban on Stem Cell Therapy for Autism

New Delhi: Doctors on Saturday welcomed the Supreme Court’s decision to prohibit the use of stem cell therapy for treating autism, a neurodevelopmental condition that affects communication, social interaction, and behaviour.

A bench comprising Justice JB Pardiwala and Justice R. Mahadevan observed that stem cell therapy lacks scientific backing and has not been recognised as a valid medical practice supported by empirical evidence. The Court ruled that any use of stem cells on patients outside approved clinical trials is unethical and would amount to medical malpractice.

Medical experts hailed the ruling, noting that several private laboratories have been exploiting families by offering unproven stem cell treatments for autism, despite the absence of scientific evidence.

“This is one of the best decisions that could have been taken, as there is currently no proof of the effectiveness of stem cell therapy in autism or any neurological disorder,” said Dr Manjari Tripathi, Head of the Neurology Department at AIIMS Delhi, speaking to IANS.

She added that many private centres in India advertise stem cell treatments for autism and conditions such as cerebral palsy, charging families between Rs 6 lakh and Rs 20 lakh, often without any improvement in patients. “Many families have lost large sums of money. The Supreme Court’s move is absolutely correct and should have come earlier,” she said.

In December 2022, the Ethics and Medical Registration Board (EMRB) under the National Medical Commission (NMC) had constituted a Committee on Stem Cell Use in Autism Spectrum Disorder (ASD). The committee stated that none of the international guidelines recommend stem cell therapy for ASD and that it should not be used in routine clinical practice.

The Court also underlined that unproven therapies cannot be claimed by patients as a matter of right. It noted that patients may be under a “therapeutic misconception,” expecting benefits from unproven treatments similar to those from standard care. Proceeding with such treatment under these circumstances, the Court said, amounts to a serious violation of medical ethics.

“Most stem cell therapies in India are unregulated and promoted through misleading advertisements without evidence. Since autism has no cure, families are often falsely lured by these companies,” Dr Tripathi added.

However, the apex court clarified that stem cell therapy, which holds potential in several medical fields, may still be permitted under strictly monitored and approved clinical research trials. Patients, it said, are free to participate in such regulated studies.

Dr Shefali Gulati, paediatric neurologist at AIIMS, referred to a recent Indian Council of Medical Research (ICMR) report based on a systematic review, which found no proven clinically meaningful benefit of stem cell therapy in autism spectrum disorder.

“Given the lack of evidence for clinical practice, stem cell therapy should be restricted to clinical trials only,” Gulati told IANS.

She noted that ongoing research includes experimental work on autism mouse models using stem cells and stem cell–derived exosomes. “Research should certainly continue, but the therapy should not be used in routine clinical practice as the evidence does not support it,” she said.

The experts emphasised the need for further rigorous research to establish the safety and efficacy of stem cell therapy in autism spectrum disorder.

With inputs from IANS