Safety and Efficacy of BMMNCin Patients With Mental Retardation
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
1 other identifier
interventional
15
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2014
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2013
CompletedFirst Posted
Study publicly available on registry
July 25, 2013
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedSeptember 17, 2014
September 1, 2014
2.2 years
July 23, 2013
September 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Binet-Kamat Test
CHANGE in IQ as measured by Binet-Kamat Test
1 YEAR
Secondary Outcomes (1)
Vineland Social Maturity Scale
baseline and 12 months
Study Arms (1)
BMMNCs
OTHERIntravenous transfer of (BMMNCs)
Interventions
Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chaitanya Hospital
Pune, Maharashtra, 411030, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ANANT E BAGUL, MS ORTHO
Chaitanya Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co -investigator
Study Record Dates
First Submitted
July 23, 2013
First Posted
July 25, 2013
Study Start
September 1, 2014
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
September 17, 2014
Record last verified: 2014-09