The Supreme Court has directed the Centre to create a dedicated online portal for patients undergoing stem cell therapy for Autism Spectrum Disorder (ASD) within six weeks. The court also made it mandatory for such patients, their parents, guardians, caregivers and also the treating medical practitioners and clinics administering such therapy to maintain an extensive database.
Regarding the other issue, the Centre stated that a multicenter randomised controlled trial (RCT) has been proposed to be set up at two tertiary care sites – one in north India and another in south India, within a period of six months. This will be funded by the Indian Council of Medical Research (ICMR). After reviewing the response, the court found that the proposed RCT does not lay down any eligibility criteria for patients already undergoing stem cell therapy for ASD. Further, there was no uniform platform for such patients or their caregivers to provide their information. The court further noted that the lack of easily accessible information about the use of stem cell therapy for ASD is a prime reason for many patients and their families to pursue such treatment.
The order, passed on October 13 and uploaded on Friday, comes in the backdrop of the court’s January 30 order prohibiting the use of stem cell therapy as a routine clinical service, directing it only to be undertaken only within an approved and monitored clinical trial or research setting. Last month, the court had directed the Centre to disclose how many applications for clinical trials were received pursuant to its January 30 order. It further asked the Centre to indicate steps being taken to shift those ASD patients already undergoing stem cell therapy as of January 30 into a regulated research framework. The Centre filed an affidavit on September 28 which said that pursuant to January 30 no application for a clinical trial had been received.
After registering on the portal, the court said that until the RCT is established, patients who commenced stem cell therapy for ASD on or before January 30 will be permitted to continue therapy, as a “strictly temporary arrangement”. “This arrangement shall be confined to existing patients and shall not be construed as recognition or approval of stem cell therapy for ASD as a permissible clinical service,” the court added.
