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Safety and Efficacy of BMMNCin Patients With Mental Retardation

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ClinicalTrials.gov Identifier: NCT01908400
Recruitment Status : Unknown
Verified September 2014 by Dr. Sachin Jamadar, Chaitanya Hospital, Pune.
Recruitment status was:  Recruiting
First Posted : July 25, 2013
Last Update Posted : September 17, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune

Brief Summary:
Mental retardation is a condition diagnosed before age 18 that includes below-average general intellectual function, and a lack of the skills necessary for daily living. Mental retardation affects about 1 - 3% of the population. There are many causes of mental retardation, but find a specific reason in only 25% of cases.Bone marrow derived stem cells are used in this condition to prove its safety and efficacy .

Condition or disease Intervention/treatment Phase
Mental Retardation Biological: Intravenous transfer of BMMNC Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Labeled Clinical Study to Evaluate the Safety and Efficacy of Autologous Bone Marrow Derived Mono Nuclear Stem Cell (BMMNCs) in Patients With Mental Retardation. It is Self Funded (Patients' Own Funding) Clinical Trial
Study Start Date : September 2014
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
BMMNCs
Intravenous transfer of (BMMNCs)
Biological: Intravenous transfer of BMMNC
Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)



Primary Outcome Measures :
  1. Binet-Kamat Test [ Time Frame: 1 YEAR ]
    CHANGE in IQ as measured by Binet-Kamat Test


Secondary Outcome Measures :
  1. Vineland Social Maturity Scale [ Time Frame: baseline and 12 months ]
    CHANGE in Social Quotient as measured by Vineland Social Maturity Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age limit: 5 -50
  • Primary diagnosis of mental retardation (IQ < 70)
  • willingness to undergo Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) transplantation.
  • To give an informed consent as well as sign the required Informed Consent Form (ICF)/video Consent for the study.
  • willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.

Exclusion Criteria:

  • Positive test results for HIV and AIDS complex ,HCV (hepatitis C virus ), HbsAg and Syphilis
  • Advanced age that may produce deteriorating cognitive or motor functioning
  • Multiple sensory or motor disabilities that will interfere with seeing the stimuli and responding to the computer
  • Poor general health

Information from the National Library of Medicine

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): NCT01908400


Contacts
Contact: Sachin P Jamadar, D.Ortho 918888788880 sac2751982@gmail.com

Locations
India
Chaitanya Hospital Recruiting
Pune,, Maharashtra, India, 411030
Contact: Sachin P Jamadar, D ORTHO    +918888788880    sac2751982@gmail.com   
Principal Investigator: Anant E Bagul, MS,Ortho         
Sponsors and Collaborators
Chaitanya Hospital, Pune
Investigators
Principal Investigator: ANANT E BAGUL, MS ORTHO Chaitanya Hospital

Responsible Party: Dr. Sachin Jamadar, Co -investigator, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier: NCT01908400     History of Changes
Other Study ID Numbers: CSCC/BMMR/2013//01
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014

Keywords provided by Dr. Sachin Jamadar, Chaitanya Hospital, Pune:
Mental retardation , stem cell,BMMNC

Additional relevant MeSH terms:
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders