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Studying the therapeutic effect of Intrathecal administration of autologous Bone marrow mononuclear cells in children with autism

Randomized controlled single blind clinical trial for evaluating safety and efficacy of autologous bone marrow mononuclear cells intrathecal transplantation in children with Autism - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100104
Enrollment
50
Registered
2026-01-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F840- Autistic disorder

Interventions

Intervention1: Intrathecal autologous BMMNC transplantation plus standard medical and rehabilitation therapy.: This randomized, controlled, single blind trial includes 50 children (ages 3 15) diagnose

Sponsors

NeuroGen Brain and Spine Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who are diagnosed as Autism on the basis of DSM V criteria 2. Patients whose parents are willing to give an informed written consent 3. Patients whose parents agree to adhere to the protocol and are willing to come for mandatory follow up assessments at regular intervals.

Exclusion criteria

Exclusion criteria: 1.Patients with other co-morbid neurodevelopmental disorders like mental retardation or cerebral palsy. 2.Patients with present malignancies or history of malignancies 3.Patients with positive HIV, Hepatitis B, Hepatitis C or any other acute infections 4.Patients with severe anemia, bleeding tendency; with blood hemoglobin levels below 8 g/dl. 5.Patients with any bone marrow disorders. 6.Severe renal or liver dysfunction. 7.Uncontrolled seizures

Design outcomes

Primary

MeasureTime frame
Safety of the interventionTimepoint: 1 month 3 months 6 months

Secondary

MeasureTime frame
Efficacy of interventionTimepoint: 1 month 3 months 6 months

Countries

India

Contacts

Public ContactDr Nandini Gokulchandran

NeuroGen Brain and Spine Institute

doc.hemangi@gmail.com9819741333

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026