Safety and Efficacy of BMMNCin Patients With Mental Retardation

Phase 1

• Conditions: Mental Retardation
• Interventions: Biological: Intravenous transfer of BMMNC

• Registration Number: NCT01908400
• Lead Sponsor: 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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-23
• Study First Submitted QC: 2013-07-23
• Study First Posted: 2013-07-25
• Status Verified: 2014-09
• Study Start: 2014-09
• Last Update Submitted: 2014-09-16
• Last Update Posted: 2014-09-17
• Primary Completion: 2016-11
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMMNCs	Intravenous transfer of BMMNC	Intravenous transfer of (BMMNCs)

Primary Outcome Measures

Name	Time	Method
Binet-Kamat Test	1 YEAR	CHANGE in IQ as measured by Binet-Kamat Test

Secondary Outcome Measures

Name	Time	Method
Vineland Social Maturity Scale	baseline and 12 months	CHANGE in Social Quotient as measured by Vineland Social Maturity Scale

Trial Locations

Locations (1)

Chaitanya Hospital; 🇮🇳 Pune,, Maharashtra, India