Status:
UNKNOWN
A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism
Lead Sponsor:
Chaitanya Hospital, Pune
Conditions:
Autism
Eligibility:
All Genders
3-70 years
Phase:
PHASE1
PHASE2
Brief 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 mont...
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 ab...
Eligibility Criteria
Inclusion
- Patient should suffer from Autism.
- willingness to undergo bone marrow derived autologous cell therapy.
- patient those provide fully Informed consent form for the study.
- Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.
Exclusion
- Patients with pre - existing or Current systemic disease such as lung , liver ( exception; History of uncomplicated Hepatitis A),gastrointestinal, Cardiac , Immunodeficiency,(including HIV) Or laboratory Investigation that could cause a neurological defect.History of Life threatening Allergic or immune- mediated reaction.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01836562
Start Date
September 1 2014
End Date
June 1 2016
Last Update
September 17 2014
Active Locations (1)
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1
Chaitanya Hospital
Pune, Maharashtra, India, 411009