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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01836562

Acronym

BMCA

Enrollment

100

Registered

2013-04-22

Start date

2014-09-30

Completion date

2016-06-30

Last updated

2014-09-17

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

Conditions

Autism

Keywords

Autism stem cell MNCs

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.

Interventions

BIOLOGICALSTEM CELL THERAPY

Intra thecal injection of autologous MNC ,Intra thecal inj.of 100 millions MNC in 3 doses at 10 days interval.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
Improvement in childhood autism rating scale	6 month

Secondary

Measure	Time frame
Improvement in perfusion of brain with PET scan report	6 MONTH

Countries

India

Contacts

Primary ContactSachin P Jamadar, D.Ortho

sac2751982@gmail.com+918888788880

Backup ContactSmita S Bhoyar, B.A.M.S.PGCR

drsmitabhoyar@rediff.com9372620569

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026