drugset / Trial / NCT02805023

BGC101 (EnEPC) Autologous Cell Therapy From Patient's Own Blood for Treatment of Critical Limb Ischemia (CLI)

NCT02805023 ↗

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

EvaluationDrugModalityDoseRoute
Subject BGC101 Cell therapy — Intramuscular