drugset / Trial / NCT02742844
Clinical Trial to Investigate Efficacy and Safety of the IMP in Patients With Non Healing Wounds Originating From Ulcers
Phase 1/2
Terminated
13 enrolled
RHEACELL GmbH & Co. KG
FGK Clinical Research GmbH · collabGranzer Regulatory Consulting & Services · collabTiceba GmbH · collab
NaSingle-groupOpen-labelTreatment
Summary
The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction) and safety (by monitoring occurring adverse events) of the investigational medicinal product APZ2 after one single application on chronic venous leg ulcer wounds.
Timeline
- Start
- 2016-08
- Primary completion
- 2019-01-15
- Completion
- 2019-01-15
Outcome
Outcome not reported
Stopped (Enrollment): “COVID-19 pandemic and patient recruitment issues”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | APZ2 | Cell therapy | 500000 cells | Topical |