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| Name | Class |
|---|---|
| Signature Biologics | UNKNOWN |
The primary objective of this study is to provide UC-MSC treatment to patients with DMD.
Secondary objectives will be to further evaluate treatment-related adverse events as well as changes in DMD-related functional testing/assessments, blood laboratories, and inflammation related biomarker levels over time.
The study will enroll ambulatory male participants between the ages of 5 and 10, who will receive four, 3-day intravenous dose cycles of UC-MSC treatment, each administered every three months. Participants will be closely monitored throughout the study period for treatment-related adverse events and changes in DMD-related functional assessments at specific follow-up intervals through 24 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) | Biological | Umbilical cord-derived mesenchymal stem cells administered intravenously. |
Inclusion Criteria:
Exclusion Criteria:
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Study participants will be ambulatory males aged 5-10 with genetically confirmed DMD.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Avelar, AS | Contact | 714-616-1791 | jennifer.avelar@neuromdcenter.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology Rare Disease Center | Available | Denton | Texas | 76208 | United States |
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| ID | Term |
|---|---|
| D020388 | Muscular Dystrophy, Duchenne |
| ID | Term |
|---|---|
| D009136 | Muscular Dystrophies |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |