Back to resultsStem Cell Therapy in Duchenne Muscular Dystrophy
Primary Purpose
Duchenne Muscular Dystrophy
Status
Withdrawn
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Stem Cell
Sponsored by
About this trial
This is an interventional treatment trial for Duchenne Muscular Dystrophy focused on measuring Duchenne muscular dystrophy, Autologous Bone marrow Mononuclear cell therapy, Stem Cells
Eligibility Criteria
Inclusion Criteria:
- age group of 3-25 years
- Duchenne muscular dystrophy diagnosed on the basis of clinical presentation
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
bone marrow mononuclear cell transplantation
Outcomes
Primary Outcome Measures
Manual Muscle Testing
Secondary Outcome Measures
Brooke and Vignos Scale
Full Information
NCT ID
NCT02241434
First Posted
September 12, 2014
Last Updated
October 23, 2018
Sponsor
Neurogen Brain and Spine Institute
1. Study Identification
Unique Protocol Identification Number
NCT02241434
Brief Title
Stem Cell Therapy in Duchenne Muscular Dystrophy
Official Title
The Role of Autologous Bone Marrow Mononuclear Cell Therapy in Duchenne Muscular Dystrophy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
June 2016 (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 in patients with Duchenne Muscular Dystrophy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duchenne Muscular Dystrophy
Keywords
Duchenne muscular dystrophy, Autologous Bone marrow Mononuclear cell therapy, Stem Cells
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
Arm Description
bone marrow mononuclear cell transplantation
Intervention Type
Biological
Intervention Name(s)
Stem Cell
Intervention Description
Intrathecal autologous bone marrow mononuclear cell transplantation
Primary Outcome Measure Information:
Title
Manual Muscle Testing
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Brooke and Vignos Scale
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age group of 3-25 years
Duchenne muscular dystrophy diagnosed on the basis of clinical presentation
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
Learn more about this trial
Stem Cell Therapy in Duchenne Muscular Dystrophy
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