A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism (BMCA)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01836562 |
Recruitment Status : Unknown
Verified September 2014 by Dr. Sachin Jamadar, Chaitanya Hospital, Pune.
Recruitment status was: Recruiting
First Posted : April 22, 2013
Last Update Posted : September 17, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Autism | Biological: STEM CELL THERAPY | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | September 2014 |
Estimated Primary Completion Date : | June 2016 |
Estimated Study Completion Date : | June 2016 |
Arm | Intervention/treatment |
---|---|
STEM CELL
intra thecal injection of MNC stem cell therapy
|
Biological: STEM CELL THERAPY
Intra thecal injection of autologous MNC ,Intra thecal inj.of 100 millions MNC in 3 doses at 10 days interval.
Other Name: Intra thecal injection of autologous MNC |
- Improvement in childhood autism rating scale [ Time Frame: 6 month ]
- Improvement in perfusion of brain with PET scan report [ Time Frame: 6 MONTH ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 3 Years to 70 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836562
Contact: Sachin P Jamadar, D.Ortho | +918888788880 | sac2751982@gmail.com | |
Contact: Smita S Bhoyar, B.A.M.S.PGCR | 9372620569 | drsmitabhoyar@rediff.com |
India | |
Chaitanya Hospital | Recruiting |
Pune, Maharashtra, India, 411009 | |
Contact: Sachin P Jamadar, D ORTHO +918888788880 sac2751982@gmail.com | |
Contact: Smita S Bhoyar, BAMS.PGCR 9372620569 drsmitabhoyar@rediffmail.com | |
Principal Investigator: Dr, Anant E Bagul, MS |
Principal Investigator: | ANANT E BAGUL, M.S | CHAITANYA HOSPITAL |
Responsible Party: | Dr. Sachin Jamadar, CO-Investigator, Chaitanya Hospital, Pune |
ClinicalTrials.gov Identifier: | NCT01836562 |
Other Study ID Numbers: |
00105 |
First Posted: | April 22, 2013 Key Record Dates |
Last Update Posted: | September 17, 2014 |
Last Verified: | September 2014 |
Autism stem cell MNCs |
Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders |