NCT01908400UnknownPhase 1
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
Chaitanya Hospital, Pune1 site in 1 country15 target enrollmentStarted: September 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Binet-Kamat Test
Study Overview
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 50 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
BMMNCs
Other
Intravenous transfer of (BMMNCs)
Intervention: Intravenous transfer of BMMNC (Biological)
Outcomes
Primary Outcomes
Binet-Kamat Test
Time Frame: 1 YEAR
CHANGE in IQ as measured by Binet-Kamat Test
Secondary Outcomes
- Vineland Social Maturity Scale(baseline and 12 months)
Investigators
Dr. Sachin Jamadar
Co -investigator
Chaitanya Hospital, Pune
Study Sites (1)
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