Stem cell therapy cannot be offered as a clinical service for autism: Supreme Court, Pg10

Key Highlights:

• The Supreme Court ruled that stem cell therapies cannot be offered as a clinical service for Autism Spectrum Disorder (ASD) outside approved clinical trials.
• The court criticised the Union government for failing to regulate unproven stem cell therapies for ASD.
• A dedicated authority for regulatory oversight over stem cell research across the country has been directed to be constituted by the government.
• The court stated that using stem cells in ASD treatment lacks sufficient scientific evidence regarding its effectiveness and safety.

Detailed Insights:

• The ruling came in response to petitions highlighting the promotion and administration of stem cell therapy for ASD treatment by clinics, despite being in the experimental stage.
• The court emphasized that consent for stem cell therapy is invalid without adequate disclosure of risks, benefits, and alternatives, as per established medical practice.
• The petitions argued that the government's allowance of such stem cell therapies violates the New Drugs and Clinical Trial Rules, 2019.
• The court observed that doctors lack adequate information to provide patients regarding the efficacy and safety of therapeutic use of stem cells in ASD.

Key Concepts Involved:

• Stem Cell Therapy: The use of stem cells to treat or prevent a disease or condition.
• Autism Spectrum Disorder (ASD): A developmental disability that can cause significant social, communication and behavioral challenges.
• New Drugs and Clinical Trial Rules, 2019: Regulations governing the approval and conduct of clinical trials for new drugs in India.

Stem Cell Therapy