The Supreme Court has sought a detailed account of clinical trials for stem cell therapy for Autism Spectrum Disorder (ASD), asking the Centre to disclose whether any applications for such trials have been received since its January judgment and what steps have been taken to move patients already undergoing the controversial treatment into a regulated research framework.
A bench of justices JB Pardiwala and R Mahadevan also directed the Centre to place before it details of all approved or proposed clinical trials for stem cell therapy for ASD, the institutions involved and their capacity, if any, to accommodate patients who were already receiving the therapy when the court delivered its judgment on January 30.
The order assumes significance as the court had in January ruled that stem cell therapy for ASD cannot be offered as a routine clinical service or commercial treatment and must be undertaken only within an approved and monitored clinical trial or research setting.
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Not approved for routine treatment
As per the ministry of health and family welfare, stem cell therapy is not approved as routine treatment and it is only permitted for research purposes in certain conditions listed by the ministry, with autism not being one of them. In an order issued in March, the Indian Council of Medical Research (ICMR) said, “Stem cell therapies in routine practice shall be permitted only for disease conditions specified in the list of MHoFW approved indications as standard care… Other than the approved indications, stem cell therapy is permissible only in the context of research.”
{{/usCountry}}As per the ministry of health and family welfare, stem cell therapy is not approved as routine treatment and it is only permitted for research purposes in certain conditions listed by the ministry, with autism not being one of them. In an order issued in March, the Indian Council of Medical Research (ICMR) said, “Stem cell therapies in routine practice shall be permitted only for disease conditions specified in the list of MHoFW approved indications as standard care… Other than the approved indications, stem cell therapy is permissible only in the context of research.”
{{/usCountry}}The United States’ Food and Drug Administration (FDA) has also approved stem cell therapy only for blood stem transplantation that is meant to treat blood cancers, and certain blood and immune system disorders. For all other conditions, it is experimental.
Courts asks government for regulatory mechanism
The court said the government had yet to clearly place on record how such patients were proposed to be regulated or transitioned into an appropriately approved research or clinical-trial framework. It therefore directed the Union government to disclose in its compliance affidavit whether any application had been made to the competent regulatory authority for approval or permission to conduct research or a clinical trial involving stem cell therapy for ASD. If so, the Centre has been asked to give the number of applications, dates of receipt, names of applicant institutions and the present status of each.
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The scrutiny does not stop with the government. The court has directed the Parents Forum for Stem Cells in Autism and Cerebral Palsy, the institutions and clinics administering the therapy, and parents, guardians or caregivers of patients to place on record whether they too have taken steps since the January judgment to bring the ongoing treatment within the framework of a duly approved and regulated clinical trial.
The bench has listed the matter for further hearing on September 29.