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

Chaitanya Hospital, Pune

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Autism

Treatments

Biological: STEM CELL THERAPY

Study type

Interventional

Funder types

Other

Identifiers

NCT01836562

00105

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

3 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.