Duchenne Muscular Dystrophy Clinical Trial
Official title:
The Role of Autologous Bone Marrow Mononuclear Cell Therapy in Duchenne Muscular Dystrophy
| NCT number | NCT02241434 |
| Other study ID # | NGBSI-13 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | Phase 1 |
| First received | |
| Last updated | |
| Start date | January 2009 |
| Est. completion date | June 2016 |
| Verified date | October 2018 |
| Source | Neurogen Brain and Spine Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study was to study the effect of stem cell therapy in patients with Duchenne Muscular Dystrophy.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Years to 25 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| India | Neurogen brain and spine institute | Navi Mumbai | Maharashtra |
| Lead Sponsor | Collaborator |
|---|---|
| Neurogen Brain and Spine Institute |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Manual Muscle Testing | 1 year | ||
| Secondary | Brooke and Vignos Scale | 1 year |
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