Safety and Efficacy of BMMNCin Patients With Mental Retardation

Mental Retardation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01908400
• Other study ID #: CSCC/BMMR/2013//01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 23, 2013
• Last updated: September 16, 2014
• Start date: September 2014
• Est. completion date: November 2016

Study information

• Verified date: September 2014
• Source: Chaitanya Hospital, Pune
• Contact: Sachin P Jamadar, D.Ortho
• Phone: 918888788880
• Email: sac2751982[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 50 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intellectual Disability
• Mental Retardation

Intervention

Biological:
• 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)

Locations

Country	Name	City	State
India	Chaitanya Hospital	Pune,	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Chaitanya Hospital, Pune

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binet-Kamat Test	CHANGE in IQ as measured by Binet-Kamat Test	1 YEAR	No
Secondary	Vineland Social Maturity Scale	CHANGE in Social Quotient as measured by Vineland Social Maturity Scale	baseline and 12 months	No