drugset / Trial / NCT02501018
Study to Assess the Efficacy and Safety of CLBS12 in Patients with Critical Limb Ischemia (CLI)
RandomizedParallel-groupOpen-labelTreatment
Summary
A prospective, open label, controlled, randomized, double arm, multi-center study to assess the efficacy and safety of CLBS12 in patients with critical limb ischemia (CLI) due to arteriosclerosis obliterans (ASO) with a single arm sub-study to assess the safety and potential efficacy of CLBS12 in patients with CLI due to Buerger's Disease (BD).
Timeline
- Start
- 2017-11-01
- Primary completion
- 2022-05-19
- Completion
- 2022-05-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rHIV7-shI-TAR-CCR5RZ-transduced Hematopoietic Stem/Progenitor Cells | Unknown | 1e+06 cells/kg | Intramuscular |