drugset / Trial / NCT03111238
The Efficacy and Safety of REX-001 to Treat Ischemic Rest Pain in Subjects With CLI Rutherford Category 4 and DM
Phase 3
Terminated
3 enrolled
Ixaka Ltd
Andalusian Network for Design and Translation of Advanced Therapies · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 4. Minimisation will be used to assign eligible subjects in a 2:1 ratio to receive a single intra-arterial administration of REX-001 or matching placebo into the index limb.
Timeline
- Start
- 2017-04-05
- Primary completion
- 2021-03-31
- Completion
- 2021-03-31
Outcome
Outcome not reported
Stopped: “Stopped due to inactivity”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | REX-001 | Cell therapy | — | Other |