drugset / Trial / NCT04971161
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of CVU (Phase IIb)
RandomizedParallel-groupDouble-blindTreatment
Summary
The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction of CVUs) and safety (by monitoring adverse events \[AEs\]) of three dose groups of the investigational medicinal product (IMP) allo-APZ2-CVU, topically administered on target wounds of patients with CVU compared to placebo.
Timeline
- Start
- 2021-08-18
- Primary completion
- 2025-11-25
- Completion
- 2025-11-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | allo-APZ2-CVU | Cell therapy | 1e+06 unknown | Topical |
| Subject | allo-APZ2-CVU | Cell therapy | 3e+06 unknown | Topical |
| Subject | allo-APZ2-CVU | Cell therapy | 6e+06 unknown | Topical |