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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
Sponsor:
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune

Tracking Information
First Submitted Date  ICMJE February 26, 2013
First Posted Date  ICMJE April 22, 2013
Last Update Posted Date September 17, 2014
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2013)
Improvement in childhood autism rating scale [ Time Frame: 6 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01836562 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2013)
Improvement in perfusion of brain with PET scan report [ Time Frame: 6 MONTH ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autism
Intervention  ICMJE 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
Study Arms  ICMJE STEM CELL
intra thecal injection of MNC stem cell therapy
Intervention: Biological: STEM CELL THERAPY
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 19, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2016
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01836562
Other Study ID Numbers  ICMJE 00105
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Sachin Jamadar, Chaitanya Hospital, Pune
Study Sponsor  ICMJE Chaitanya Hospital, Pune
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: ANANT E BAGUL, M.S CHAITANYA HOSPITAL
PRS Account Chaitanya Hospital, Pune
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP