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Safety and Efficacy of BMMNCin Patients With Mental Retardation

Primary Purpose

Mental Retardation

Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Intravenous transfer of BMMNC
Sponsored by
Chaitanya Hospital, Pune
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Retardation focused on measuring Mental retardation , stem cell,BMMNC

Eligibility Criteria

5 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chaitanya HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

BMMNCs

Arm Description

Intravenous transfer of (BMMNCs)

Outcomes

Primary Outcome Measures

Binet-Kamat Test
CHANGE in IQ as measured by Binet-Kamat Test

Secondary Outcome Measures

Vineland Social Maturity Scale
CHANGE in Social Quotient as measured by Vineland Social Maturity Scale

Full Information

First Posted
July 23, 2013
Last Updated
September 16, 2014
Sponsor
Chaitanya Hospital, Pune
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1. Study Identification

Unique Protocol Identification Number
NCT01908400
Brief Title
Safety and Efficacy of BMMNCin Patients With Mental Retardation
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chaitanya Hospital, Pune

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Retardation
Keywords
Mental retardation , stem cell,BMMNC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BMMNCs
Arm Type
Other
Arm Description
Intravenous transfer of (BMMNCs)
Intervention Type
Biological
Intervention Name(s)
Intravenous transfer of BMMNC
Intervention Description
Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)
Primary Outcome Measure Information:
Title
Binet-Kamat Test
Description
CHANGE in IQ as measured by Binet-Kamat Test
Time Frame
1 YEAR
Secondary Outcome Measure Information:
Title
Vineland Social Maturity Scale
Description
CHANGE in Social Quotient as measured by Vineland Social Maturity Scale
Time Frame
baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sachin P Jamadar, D.Ortho
Phone
918888788880
Email
sac2751982@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANANT E BAGUL, MS ORTHO
Organizational Affiliation
Chaitanya Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaitanya Hospital
City
Pune,
State/Province
Maharashtra
ZIP/Postal Code
411030
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sachin P Jamadar, D ORTHO
Phone
+918888788880
Email
sac2751982@gmail.com
First Name & Middle Initial & Last Name & Degree
Anant E Bagul, MS,Ortho

12. IPD Sharing Statement

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Safety and Efficacy of BMMNCin Patients With Mental Retardation

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