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Cell Therapy in Limb Girdle Muscular Dystrophy

Primary Purpose

Limb Girdle Muscular Dystrophy

Status
Withdrawn
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Stem Cell
Sponsored by
Neurogen Brain and Spine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Limb Girdle Muscular Dystrophy focused on measuring Limb Girdle Muscular Dystrophy, Autologous Bone Marrow Mononuclear cell therapy, Stem Cell

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age group of 15 years-60 years
  • limb girdle muscular dystrophy diagnosed on the basis of clinical presentation
  • Electromyographic and Nerve Conduction velocity findings

Exclusion Criteria:

  • presence of respiratory distress
  • presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus
  • malignancies
  • acute medical conditions such as respiratory infection, fever, hemoglobin less than 8, bleeding tendency, bone marrow disorder, left ventricular ejection fraction < 30%
  • pregnancy or breastfeeding

Sites / Locations

  • Neurogen brain and spine institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem Cell

Arm Description

Outcomes

Primary Outcome Measures

Change in Functional Independence Measure (FIM) scale
Functional Independence Measure scale assesses the patients ability to carry out activities of daily living. At the follow up of 1 year, every patient in this study will be reevaluated on this scale.

Secondary Outcome Measures

Change in Manual Muscle Testing (MMT)
Manual muscle testing is a procedure for the evaluation of the function and strength of individual muscles and muscle groups based on the effective performance of a movement in relation to the forces of gravity and manual resistance. On the follow up after 1 year, every patient will be reassessed on MMT to record changes in their muscle strength after stem cell therapy.

Full Information

First Posted
September 12, 2014
Last Updated
October 23, 2018
Sponsor
Neurogen Brain and Spine Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02245711
Brief Title
Cell Therapy in Limb Girdle Muscular Dystrophy
Official Title
Intrathecal Autologous Mononuclear Cell Therapy for Limb Girdle Muscular Dystrophy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Study Start Date
December 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurogen Brain and Spine Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study was to study the effect of stem cell therapy on Limb Girdle Muscular Dystrophy patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Limb Girdle Muscular Dystrophy
Keywords
Limb Girdle Muscular Dystrophy, Autologous Bone Marrow Mononuclear cell therapy, Stem Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stem Cell
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Stem Cell
Primary Outcome Measure Information:
Title
Change in Functional Independence Measure (FIM) scale
Description
Functional Independence Measure scale assesses the patients ability to carry out activities of daily living. At the follow up of 1 year, every patient in this study will be reevaluated on this scale.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in Manual Muscle Testing (MMT)
Description
Manual muscle testing is a procedure for the evaluation of the function and strength of individual muscles and muscle groups based on the effective performance of a movement in relation to the forces of gravity and manual resistance. On the follow up after 1 year, every patient will be reassessed on MMT to record changes in their muscle strength after stem cell therapy.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age group of 15 years-60 years limb girdle muscular dystrophy diagnosed on the basis of clinical presentation Electromyographic and Nerve Conduction velocity findings Exclusion Criteria: presence of respiratory distress presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus malignancies acute medical conditions such as respiratory infection, fever, hemoglobin less than 8, bleeding tendency, bone marrow disorder, left ventricular ejection fraction < 30% pregnancy or breastfeeding
Facility Information:
Facility Name
Neurogen brain and spine institute
City
Navi Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400706
Country
India

12. IPD Sharing Statement

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Cell Therapy in Limb Girdle Muscular Dystrophy

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