The Supreme Court of India ruled that stem cell therapy cannot be offered as a clinical treatment for Autism Spectrum Disorder (ASD).
Background
- The judgment arose from petitions highlighting the widespread promotion and administration of stem cell therapy for ASD by private clinics.
- Clinics were found to be touting experimental therapy as a “treatment” or “cure”, creating false hope.
- Financial Exploitation: Families often incurred huge financial costs in pursuit of these unproven interventions.
Supreme Court’s Ruling
- Clinical Use Prohibited: The Court categorically ruled that stem cell ‘therapies’ for ASD cannot be administered as routine clinical treatment.
- Lack of Scientific Evidence:
- The court observed that there is a “dearth of established scientific evidence” on both the effectiveness and safety of stem cell therapy for ASD.
- Administering stem cell therapy based on uncertain scientific knowledge fails the “reasonable standard of care” owed by doctors to patients.
- Informed Consent Not Valid: The Court held that valid informed consent is impossible in the absence of adequate scientific data.
- Meaning of Informed Consent: Consent must be an “informed authorisation”, grounded in disclosure of the nature, procedure, purpose, benefits, risks, alternatives, and consequences of refusing treatment.
- No Right to Demand Stem Cell Therapy:
- The Court clarified that parents, guardians, or caregivers cannot demand stem cell therapy as a clinical service for children with ASD.
- Patient autonomy does not create an entitlement to unsafe or unproven medical interventions.
- Regulatory Authority: The Supreme Court directed the government to constitute a dedicated regulatory authority for nationwide oversight of stem cell research.
Stem Cell Therapy
- Stem cell therapy is a form of regenerative medicine that aims to repair or replace damaged cells and tissues.
- It works mainly by reducing inflammation and modulating immune responses, which can support healing in several conditions.
- Applications of Stem Cell Therapy:
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- Regenerative Medicine: Stem cells can help repair or replace damaged tissues such as heart muscle, cartilage, or nerve cells.
- Chronic Diseases: Research is exploring stem cell-based approaches for conditions like diabetes, Parkinson’s disease, Alzheimer’s disease, and spinal cord injury.
- Immune Disorders and Cancer Care: Stem cells may be used to modify or strengthen immune responses, including therapeutic strategies for autoimmune diseases and certain cancers.
- Orthopaedics: Stem cell therapy is explored for orthopaedic injuries and degenerative conditions like osteoarthritis
- Stem cells are primitive (unspecialised) cells that can divide and develop into different types of specialised cells in the body.
- Key Feature: Under suitable conditions, stem cells can:
- Self-renew (make more stem cells), and
- Differentiate into specialised cells like blood cells, nerve cells, bone cells, muscle cells, etc.
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Regulatory Status of Stem Cell Therapy in India
- National Guidelines for Stem Cell Research, 2017:
- Jointly formulated by the Department of Biotechnology (DBT) and Indian Council of Medical Research (ICMR).
- There are no approved indications for stem cell therapy, except hematopoietic stem cell transplantation (HSCT) for hematological disorders.
- All other stem cell therapies are classified as investigational and may be conducted only as clinical trials, after obtaining necessary regulatory approvals.
- Use of stem cells outside approved clinical trials is considered unethical and impermissible
What is Autism Spectrum Disorder (ASD)
- Nature of Condition: ASD is a neurodevelopmental disorder that affects how individuals communicate, behave, and interact socially.
- Spectrum Character: Autism exists on a spectrum, meaning symptoms and their severity vary widely among individuals.
- Individuals with ASD may display a wide range of intellectual functioning, ranging from profound impairment to above-average or exceptional abilities.
- Causes: The exact causes of ASD are not fully understood, but research indicates a combination of genetic and environmental factors that increase the likelihood of a child developing the condition
- Early Signs and Symptoms:
- Age of Onset: Most children show signs of autism before the age of three years.
- Communication Indicators: Delayed speech or language development, limited eye contact, and reduced facial expressions.
- Social Interaction Difficulties: Challenges in understanding social cues and recognising emotions in others.
- Behavioural Patterns: Repetitive behaviours and strong attachment to routines are common.
- Sensory Sensitivities: Certain sounds, textures, lights or environments may trigger strong reactions.
- Educational Challenges: Difficulty adapting to school environments may be observed
- Treatment and Management:
- There is no permanent cure for autism; however, its symptoms can be effectively managed through early and evidence-based interventions.
- Speech Therapy: Focuses on improving communication and language skills.
- Occupational Therapy: Helps develop motor skills and daily living abilities.
- Behavioural Therapy: Aims to improve social interaction, behaviour regulation and independence.
- Global and National Initiatives:
- Global framework: The UN Convention on the Rights of Persons with Disabilities (UNCRPD) and the Sustainable Development Goals (SDGs) support the rights, inclusion and dignity of persons with disabilities, including autism.
- World Health Organization (2014): Adopted a resolution titled “Comprehensive and Coordinated Efforts for the Management of Autism Spectrum Disorders”, backed by over 60 countries.
- United Nations General Assembly declared 2 April as World Autism Awareness Day to promote awareness, acceptance and inclusion worldwide.
- India: The Rights of Persons with Disabilities Act, 2016 expanded the list of recognised disabilities from 7 to 21 and explicitly included Autism Spectrum Disorder
31 Jan 2026
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