Doctors welcome Supreme Court ban on stem cell therapy for autism

New Delhi, Jan 31 (IANS) Doctors on Saturday welcomed the Supreme Court’s order against the use of stem cell therapy to treat autism — a neurodevelopmental condition affecting communication, social interaction, and behaviour.

A bench comprising Justice JB Pardiwala and Justice R Mahadevan noted that stem cell therapy lacks “scientific support and has not been recognised as a sound medical practice backed by empirical evidence”.

The Bench ruled that “every use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice.”

Doctors welcomed the move by SC as many private labs are minting money from patients over the promise of treatment for autism, amid a lack of scientific evidence.

“This is absolutely the best thing that can happen because there is no proof or evidence of the utility of stem cell therapy in autism or in any neurological disorder as of now,” Dr Manjari Tripathi, Head of Department, Neurology, AIIMS Delhi, told IANS.

“Many people in India, and private labs, are advertising stem cells for autism and other disorders like cerebral palsy and charging patients anywhere between Rs 6 and 20 lakh. Many families have lost money with no improvement. So, it’s a correct move by the Supreme Court, and should have come earlier,” she added.

Notably, the Ethics and Medical Registration Board (EMRB), under the National Medical Commission (NMC), had, in December 2022, constituted the Committee on Stem Cell Use in Autism Spectrum Disorder (ASD).

It had stated that none of the current international guidelines recommend stem cell therapy as a treatment for ASD and added that the therapy is not recommended as a treatment for ASD in clinical practice.

Moreover, the Court also noted that an unproven therapy cannot be “demanded by a patient as a matter of right”.

It stated “patients may remain under therapeutic misconception and anticipate such results from an unproven treatment as may be expected from routine treatment and care. Following through with the medical treatment even when patients are under such a misconception is, in our view, a gross violation of medical ethics,” the Court noted.

“Most stem cell therapies are unregulated in India and are promoted based on no evidence, and fake advertisements. While these disorders have no cure, many people are falsely lured by these companies,” Tripathi said.

The apex Court, however, added that the advanced therapy, which holds promise in several medical fields, can still be approved for monitored clinical research trials. It added that the patients have the liberty to participate in approved and regulated clinical trials.

Dr Shefali Gulati, paediatric neurologist at AIIMS, cited a recent ICMR report, based on a systematic review, which “conclusively found no proven benefit for clinically meaningful response in autism spectrum disorder through stem cell therapy.”

As there is not much evidence available for clinical practise, it should be used only in a clinical trial format and not for clinical practise, Gulati told IANS.

“We are doing a trial in which we have been working on stem cells in mice with autism. We have been working on exosomes derived from mesenchymal stem cells to work in the autism mouse model. While research has been encouraged, the therapy should not be used in clinical practise because the evidence does not support it,” she said.

The expert called for more research “to generate evidence regarding the efficacy and safety of stem cells in ASD”.

–IANS

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