Safety and Efficacy of BMMNCin Patients With Mental Retardation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-11-30

Brief Summary

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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 .

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Detailed Description

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Conditions

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Mental Retardation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMMNCs

Intravenous transfer of (BMMNCs)

Group Type OTHER

Intravenous transfer of BMMNC

Intervention Type BIOLOGICAL

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

Interventions

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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)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes