Trial record 2 of 130 for:    Open Studies | "Mental Retardation"

Safety and Efficacy of Mesenchymal Stem Cell in Patients With Mental Retardation

This study is not yet open for participant recruitment.
Verified October 2013 by Chaitanya Hospital, Pune
Sponsor:
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier:
NCT01908400
First received: July 23, 2013
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Mental Retardation
Biological: Intravenous transfer of Mesenchymal Stem Cell ( MSCs )
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Labeled Clinical Study to Evaluate the Safety and Efficacy of Bone Marrow Derived Mesenchymal Stem Cell in Patients With Mental Retardation.

Resource links provided by NLM:


Further study details as provided by Chaitanya Hospital, Pune:

Primary Outcome Measures:
  • Binet-Kamat Test [ Time Frame: 1 YEAR ] [ Designated as safety issue: No ]
    CHANGE in IQ as measured by Binet-Kamat Test


Secondary Outcome Measures:
  • Vineland Social Maturity Scale [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    CHANGE in Social Quotient as measured by Vineland Social Maturity Scale


Estimated Enrollment: 15
Study Start Date: November 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Mesenchymal stem cell
Intravenous transfer of Mesenchymal Stem Cell ( MSCs )
Biological: Intravenous transfer of Mesenchymal Stem Cell ( MSCs )
Intervention therapy , Total 6 doses ,in 30 days ,in 7days interval Intravenous transfer of Bone marrow derived Mesenchymal Stem Cell ( MSCs )

  Eligibility

Ages Eligible for Study:   5 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age limit: 5 -50
  • Primary diagnosis of mental retardation (IQ < 70)
  • willingness to undergo Bone marrow and umbilical cord derived Mesenchymal stem cell 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01908400

Contacts
Contact: Sachin P Jamadar, D.Ortho 918888788880 sac2751982@gmail.com
Contact: Smita S Bhoyar, B.A.M.S.PGCR 9372620569 drsmitabhoyar@rediff.com

Locations
India
Chaitanya Hospital Not yet 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
  More Information

No publications provided

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
Study First Received: July 23, 2013
Last Updated: October 8, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Chaitanya Hospital, Pune:
Mental retardation ,Mesenchymal stem cell,

Additional relevant MeSH terms:
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014