drugset / Trial / NCT03339973
Allogeneic ABCB5-positive Stem Cells for Treatment of PAOD
Phase 1/2
Terminated
24 enrolled
RHEACELL GmbH & Co. KG
FGK Clinical Research GmbH · collabGranzer Regulatory Consulting & Services · collabTiceba GmbH · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction of Peripheral Arterial Occlusive Disease-related clinically relevant ulcers) and safety (by monitoring adverse events) of one dose of allo-APZ2-PAOD administered intramuscularly into an affected lower leg of patients with Peripheral Arterial Occlusive Disease.
Timeline
- Start
- 2018-03-05
- Primary completion
- 2020-05-15
- Completion
- 2020-05-15
Outcome
Outcome not reported
Stopped (Enrollment): “Very slow recruitment of patients and the current COVID-19 pandemic situation.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | allo-APZ2-PAOD | Unknown | 1.5e+08 cells | Intramuscular |
| Subject | allo-APZ2-PAOD | Unknown | 2.25e+08 cells | Intramuscular |