Trials / Available
AvailableNCT06579352
Expanded Access Study of UC-MSC in DMD Patients
Intermediate Size Expanded Access Study of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) In Patients With Duchenne Muscular Dystrophy
- Status
- Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- MED Institute Inc. · Industry
- Sex
- Male
- Age
- 5 Years – 10 Years
- Healthy volunteers
- —
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) | Umbilical cord-derived mesenchymal stem cells administered intravenously. |
Timeline
- First posted
- 2024-08-30
- Last updated
- 2024-08-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06579352. Inclusion in this directory is not an endorsement.