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Stem Cell Therapy in Duchenne Muscular Dystrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02241434
Recruitment Status : Withdrawn
First Posted : September 16, 2014
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute

Study Description
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Brief Summary:
The purpose of this study was to study the effect of stem cell therapy in patients with Duchenne Muscular Dystrophy.

Condition or disease Intervention/treatment Phase
Duchenne Muscular Dystrophy Biological: Stem Cell Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Autologous Bone Marrow Mononuclear Cell Therapy in Duchenne Muscular Dystrophy
Study Start Date : January 2009
Actual Primary Completion Date : January 2016
Actual Study Completion Date : June 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Stem Cell
bone marrow mononuclear cell transplantation
 Biological: Stem Cell
Intrathecal autologous bone marrow mononuclear cell transplantation


Outcome Measures
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Primary Outcome Measures :
  1. Manual Muscle Testing [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Brooke and Vignos Scale [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241434


Locations
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India
Neurogen brain and spine institute
Navi Mumbai, Maharashtra, India, 400706
Sponsors and Collaborators
Neurogen Brain and Spine Institute
More Information
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Responsible Party: Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier: NCT02241434    
Other Study ID Numbers: NGBSI-13
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Keywords provided by Neurogen Brain and Spine Institute:
Duchenne muscular dystrophy
Autologous Bone marrow Mononuclear cell therapy
Stem Cells
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
 Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked