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

Sponsors

Lead Sponsor: Chaitanya Hospital, Pune

Source 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 .

Overall Status Unknown status
Start Date September 2014
Completion Date November 2016
Primary Completion Date November 2016
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Binet-Kamat Test 1 YEAR
Secondary Outcome
Measure Time Frame
Vineland Social Maturity Scale baseline and 12 months
Enrollment 15
Condition
Intervention

Intervention Type: Biological

Intervention Name: Intravenous transfer of BMMNC

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

Arm Group Label: BMMNCs

Eligibility

Criteria:

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

Gender: All

Minimum Age: 5 Years

Maximum Age: 50 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
ANANT E BAGUL, MS ORTHO Principal Investigator Chaitanya Hospital
Overall Contact

Last Name: Sachin P Jamadar, D.Ortho

Phone: 918888788880

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Chaitanya Hospital Sachin P Jamadar, D ORTHO +918888788880 [email protected] Anant E Bagul, MS,Ortho Principal Investigator
Location Countries

India

Verification Date

September 2014

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Chaitanya Hospital, Pune

Investigator Full Name: Dr. Sachin Jamadar

Investigator Title: Co -investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: BMMNCs

Type: Other

Description: Intravenous transfer of (BMMNCs)

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov