Families representing children with autism and cerebral palsy raise concerns over ongoing treatment and clinical-trial options
NEW DELHI: A group representing parents of children with autism and cerebral palsy has approached the Supreme Court for an oral hearing on its recent ruling concerning stem-cell therapy.
The Parents Forum for Stem Cells in Autism and Cerebral Palsy said families need an opportunity to present their evidence and explain how the ruling could affect children who are already undergoing treatment.
The Forum represents around 5,000 families and held a press conference at Andhra Bhavan in New Delhi on Saturday.
Forum Says Counsel Was Not Given Oral Hearing
The Parents Forum is a respondent in Yash Charitable Trust & Ors. v. Union of India & Ors.
The association said its counsel asked to address the Supreme Court during the first hearing in January 2025. According to the Forum, the court instead asked the counsel to file written submissions.
The parents now want the court to hear their arguments orally.
The Forum said, “Our first demand is simple: hear us.”
Parents Seek Clarity for Children Already in Treatment
The Forum said the Supreme Court ruling states that stem-cell therapy for autism should not continue as routine treatment and directs children undergoing the therapy towards institutions running clinical trials.
Parents said they have not identified suitable clinical trials for their children.
They also questioned how children who are already receiving treatment can move into clinical trials if those trials impose eligibility conditions.
The families said doctors should consider each child’s existing treatment and medical records before making changes.
Doctor-Parents Share Treatment Experiences
Several parents spoke about their children’s experiences with stem-cell therapy during the press conference.
Dr. Seema Mehrotra, a mother of an autistic child and a Dental Surgeon and Rehabilitation Psychologist from Jabalpur, said she observed changes in her child’s mobility, communication, understanding and daily activities after the therapy.
Dr. Sandhya Gokavarapu, a mother of an autistic child and a Maxillofacial and Head & Neck Oncology Surgeon from Hyderabad, stressed the need for clarity around treatment continuity.
“A child already undergoing treatment cannot simply be told to stop without addressing whether an appropriate clinical trial exists and whether that child is eligible,” she said.
Arun Kumar Tiwari, Vice President of the Parents Forum and a parent of an autistic child, spoke on behalf of the association.
Deepa, a 73-year-old grandmother from Pune caring for her autistic grandchild, also shared her concerns.
Parents Submit Scientific Material
The Forum said it has submitted 82 peer-reviewed research papers, clinical records, testimonials and other documents for consideration.
The association wants the court to examine this material while reviewing the concerns raised by families.
Parents also said that children who have already undergone treatment may not automatically qualify for clinical trials, depending on the eligibility criteria.
Forum Questions Stem-Cell Regulations
The association has also raised questions about the legal and regulatory framework covering autologous stem-cell procedures.
In these procedures, doctors collect cells from a patient and return the cells to the same patient.
The Forum said the court should consider the definition of “drug” under the Drugs and Cosmetics Act, 1940, and its relationship with the New Drugs and Clinical Trials Rules, 2019.
It also referred to the regulatory role of the Central Drugs Standard Control Organisation (CDSCO).
Families Ask Court to Examine Impact of Ruling
Arun Kumar Tiwari said the families want the Supreme Court to consider both the scientific material and the practical impact of the ruling.
“We are asking the court to hear us, examine the evidence we have submitted and consider the consequences of the judgment for children who are already undergoing treatment,” he said.
The Forum has asked for an oral hearing, consideration of children’s right to health under Article 21, review of family testimonials and medical records, and an independent examination of the scientific material placed before the court.
The parents said they want a clear treatment pathway for children who are already receiving stem-cell therapy.
