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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01908400

Enrollment

Registered

2013-07-25

Start date

2014-09-30

Completion date

2016-11-30

Last updated

2014-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Retardation

Keywords

Mental retardation , stem cell,BMMNC

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 .

Interventions

BIOLOGICALIntravenous 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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Binet-Kamat Test	1 YEAR	CHANGE in IQ as measured by Binet-Kamat Test

Secondary

Measure	Time frame	Description
Vineland Social Maturity Scale	baseline and 12 months	CHANGE in Social Quotient as measured by Vineland Social Maturity Scale

Countries

India

Contacts

Primary ContactSachin P Jamadar, D.Ortho

sac2751982@gmail.com918888788880

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026