drugset / Trial / NCT04236479
Mesenchymal Stromal Cells for Infants With Congenital Heart Disease (MedCaP)
NaSingle-groupOpen-labelTreatment
Summary
The proposed study will be a prospective, open-label, single-center, safety and feasibility phase 1 trial of allogeneic bone marrow-derived mesenchymal stromal cell (BM-MSC) delivery though cardiopulmonary bypass (CPB) using a homogeneous population of infants with congenital heart disease (CHD) who will be undergoing a two-ventricle repair within the first six months of life
Timeline
- Start
- 2020-07-29
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mesenchymal stem cell | Cell therapy | 1e+06 cells/kg | Other |
| Subject | Mesenchymal stem cell | Cell therapy | 1e+07 cells/kg | Other |
| Subject | Mesenchymal stem cell | Cell therapy | 2e+07 cells/kg | Other |
| Subject | Mesenchymal stem cell | Cell therapy | 4e+07 cells/kg | Other |
| Subject | Mesenchymal stem cell | Cell therapy | 8e+07 cells/kg | Other |