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
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Improvement in childhood autism rating scale
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
STEM CELL
intra thecal injection of MNC stem cell therapy
Intervention: STEM CELL THERAPY (Biological)
Outcomes
Primary Outcomes
Improvement in childhood autism rating scale
Time Frame: 6 month
Secondary Outcomes
- Improvement in perfusion of brain with PET scan report(6 MONTH)
Investigators
Dr. Sachin Jamadar
CO-Investigator
Chaitanya Hospital, Pune