SC bars stem cell therapy for autism outside clinical trials

The Supreme Court on Friday said stem cell 'therapies' for Autism Spectrum Disorder (ASD) cannot be offered by medical practitioners as a clinical service outside an approved and monitored clinical trial setting. 

A bench of Justices J B Pardiwala and R Mahadevan said every use of stem cells in patients outside an approved clinical trial is 'unethical' and shall be considered as 'malpractice'.

However, the bench said it does not wish to leave patients who are already undergoing the therapy in any apprehension that discontinuing the same may prove to be detrimental to their well-being.

"... At the same time, we are also sure of our decision that stem cell therapy for ASD cannot continue as a commercial endeavour in the form of routine clinical treatment," it said.

The bench said, "Therefore, we direct the Secretary, Ministry of Health and Family Welfare, in consultation with the officials of AIIMS and the National Medical Council, to provide the best possible solution in this regard to ensure that such patients are able to continue receiving the therapy till the time they can be re-routed to the institutions that are conducting clinical trials."

It delivered its verdict on a plea that raised concerns relating to rampant promotion, prescription and administration of stem cell 'therapy' for treatment of ASD by several clinics across the country.

"The reasons presented in the aforesaid discussion establish that stem cell 'therapies' for ASD cannot be offered by medical practitioners as a clinical service outside an approved and monitored clinical trial/research setting. In such a scenario, the regulation of such research gains primacy," the bench said.

Patient Autonomy and Consent

Dealing with the issue of whether patient autonomy enables a person to give consent to an unproven treatment, the bench said, "We are of the considered view that a treatment cannot be demanded by a patient as a matter of right."

It said even though the patient may have voluntarily opted for such a procedure, such a choice does not amount to a valid consent to undergo the treatment due to the lack of 'adequate information' to form its basis.

"Having said so, we clarify that one would still have the liberty to participate in an approved and regulated research/clinical trial involving stem cell therapy for ASD," it said. 

Future of Stem Cell Therapy for ASD

The bench said until there is further research which establishes this as a sound and relevant medical practice, stem cell 'therapies' for ASD cannot be offered by medical practitioners as a clinical service.

Referring to the Ethics and Medical Registration Board-National Medical Commission recommendations of December 6, 2022, National Ethical Guidelines and other documents, it noted that they indicated that therapeutic use of stem cells for treatment of ASD was not recommended as routine clinical treatment.

The bench said although stem cells administered for therapeutic use in ASD are characterised as 'drugs' under the Drugs Act, 1940, the same by itself is not determinative of the fact that it is permissible to be administered as a clinical service.

It said the only circumstance in which an experimental treatment may be provided is when it is administered within an approved research or clinical trial setting. 

Action Against Errant Clinics

Regarding errant clinics/organisations, the bench said action must be taken by the appropriate authority under Section 32 and Section 40 of the Clinical Establishments (Registration and Regulation) Act, 2010, which provide for cancellation of registration and penalty.

It highlighted the 'shortfalls and fault lines' in the regulatory mechanism for stem cell research and said it is imperative to ensure that the law in this regard is clear.

"As things currently stand, the legal framework pertaining to stem cell research is fragmented and spread out across legislation with little harmony. This makes both compliance and enforcement an uphill task," it said.

The bench said obscurity in the legal regime also enables manipulation of patients' vulnerabilities by errant medical practitioners.

"Such obscurity, whether conscious or unintended, has arisen directly from legislative shortsightedness," it said. 

Recommendations for Improvement

It suggested consolidation of rules, regulations and guidelines to govern stem cell-based clinical trials and research.

The bench suggested the legislation ought to address points, including clearly defining stem cells and their derivatives and laying down a specific procedure for application for clinical trials, including a flexible yet definite list of standards or guidelines that need to be adhered to.

"We suggest that the NAC-SCRT (National Apex Committee for Stem Cell Research & Therapy) is constituted once again to ensure proper and coherent monitoring and regulation of stem cell research," the bench said.

It was unfortunate that the Centre had let the matter worsen without any suitable and timely intervention, the bench said, adding that such inaction had led to several parents and guardians seeking an unproven method of treatment for their children suffering from ASD, incurring huge financial cost and as an alternative to other approved treatments.

"It cannot be denied that various clinics, in flagrant violation of the aforesaid statutory mandate, continued to recommend and perform stem cell therapy as a routine clinical treatment for ASD because there was a lack of executive action against the same," it said.

While posting the matter after four weeks, the bench urged the Centre to consolidate and clarify the position of law for enabling its better implementation in this regard at the earliest.