drugset / Trial / NCT02805023
BGC101 (EnEPC) Autologous Cell Therapy From Patient's Own Blood for Treatment of Critical Limb Ischemia (CLI)
Phase 1/2
Active not recruiting
40 enrolled
BioGenCell Ltd.
Laniado Hospital · collabRabin Medical Center · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
Evaluate the feasibility of an autologous cell preparation composed of a mixture of cells enriched for endothelial progenitor cells (EnEPCs) and multipotent adult hematopoietic stem/progenitor cells (HSPC) (BGC101), in the treatment of patients suffering from peripheral arterial disease (PAD) with critical limb ischemia (CLI) who have not responded to optimal pharmacological treatment or control of risk factors and/or had a revascularization failure, and do not have the option of further revascularization treatment.
Timeline
- Start
- 2016-06
- Primary completion
- 2017-07
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BGC101 | Cell therapy | — | Intramuscular |