Stem Cell Therapy in Duchenne Muscular Dystrophy
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ClinicalTrials.gov Identifier: NCT02241434 |
Recruitment Status :
Withdrawn
First Posted : September 16, 2014
Last Update Posted : October 25, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Duchenne Muscular Dystrophy | Biological: Stem Cell | Phase 1 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Stem Cell
bone marrow mononuclear cell transplantation
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Biological: Stem Cell
Intrathecal autologous bone marrow mononuclear cell transplantation |
- Manual Muscle Testing [ Time Frame: 1 year ]
- Brooke and Vignos Scale [ Time Frame: 1 year ]

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Ages Eligible for Study: | 3 Years to 25 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
India | |
Neurogen brain and spine institute | |
Navi Mumbai, Maharashtra, India, 400706 |
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 |
Duchenne muscular dystrophy Autologous Bone marrow Mononuclear cell therapy Stem Cells |
Muscular Dystrophies Muscular Dystrophy, Duchenne Muscular Disorders, Atrophic Muscular Diseases Musculoskeletal Diseases |
Neuromuscular Diseases Nervous System Diseases Genetic Diseases, Inborn Genetic Diseases, X-Linked |