drugset / Trial / NCT06464588
A Phase 1 Open-Label Study of the Safety of Intravenous Allogeneic Neonatal Mesenchymal Cells (nMSCs) in Young Adult (1A) and Pediatric (1B) Patients With Dilated Cardiomyopathy (DCM)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a Phase 1 study to determine the safety and efficacy of allogeneic neonatal mesenchymal stromal cells (nMSCs) for the treatment of Dilated Cardiomyopathy. The purpose of the study is to help doctors and scientists learn if allogeneic neonatal mesenchymal stromal cells (nMSCs) infusions are a safe and effective way to improve cardiac function and left ventricular ejection fraction.
Timeline
- Start
- 2025-07-14
- Primary completion
- 2027-07
- Completion
- 2027-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Allogeneic Neonatal mesenchymal stromal cells | Cell therapy | 700000 cells/kg | Intravenous |
| Subject | Allogeneic Neonatal mesenchymal stromal cells | Cell therapy | 1.43e+06 cells/kg | Intravenous |
| Subject | Allogeneic Neonatal mesenchymal stromal cells | Cell therapy | 2.85e+06 cells/kg | Intravenous |
| Subject | Allogeneic Neonatal mesenchymal stromal cells | Cell therapy | 5e+07 cells | Intravenous |
| Subject | Allogeneic Neonatal mesenchymal stromal cells | Cell therapy | 1e+08 cells | Intravenous |
| Subject | Allogeneic Neonatal mesenchymal stromal cells | Cell therapy | 2.5e+08 cells | Intravenous |