NCT01836562

A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism

A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism. It is Self Funded (Patients' Own Funding) Clinical Trial

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Chaitanya Hospital, Pune · Academic / Other
• Sex: All
• Age: 3 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This clinical trial is a single Arm, single centre to check the safety and efficacy of bone marrow derived autologous mono nuclear cells (MNC) (100 million per dose). Trial to be conducted for 36 months.

Detailed description

Autism is a developmental disorder that appears in the first 3 years of life, and affects the brain's normal development of social and communication skills. Autism is a physical condition linked to abnormal biology and chemistry in the brain. The exact causes of these abnormalities remain unknown,Symptoms-Children with autism typically have difficulties in: Pretend play, Social interactions, Verbal and non-verbal communication. Some children with autism appear normal before age 1 or 2 and then suddenly "regress" and lose language or social skills they had previously gained. This is called the regressive type of autism. People with autism may: Be overly sensitive in sight, hearing, touch, smell, or taste.

Conditions

• Autism

Interventions

Type	Name	Description
BIOLOGICAL	STEM CELL THERAPY	Intra thecal injection of autologous MNC ,Intra thecal inj.of 100 millions MNC in 3 doses at 10 days interval.

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2013-04-22
• Last updated: 2014-09-17

Locations

1 site across 1 country: India