NCT02805023

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

Phase 1/2, Open Label & Double Blind Randomized Placebo-controlled Study to Assess the Feasibility of BGC101 (EnEPC) in the Treatment of Peripheral Arterial Disease (PAD) With Critical Limb Ischemia (CLI)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: BioGenCell Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

BGC101 is designed to treat peripheral vascular disease in patients suffering from Critical Leg Ischemia (CLI) also referred to as chronic limb threatening ischemia (CLTI). This part of the study is designed as a placebo double-blind randomized controlled trial (CRT) assessing the safety and efficacy of BGC101 in 45 eligible subjects in 2 Arms: Arm A: BGC101 treatment and Arm B: Placebo treatment. The Arm A:Arm B ratio is 2:1 A single dose treatment of the personalized cells by intramuscular injections into the affected leg takes less than 10 minutes. Cells from a standard blood draw (with no pre-treatment, bone marrow aspiration, mobilization or apheresis) are transformed, within a day, into the investigational medicinal product BGC101. BGC101, intended for autologous use, is a 'ready-to-use' cell suspension in prefilled syringes.

Conditions

• Chronic Limb-Threatening Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Disease

Interventions

Type	Name	Description
BIOLOGICAL	BGC101 (autologous EnEPC preparation)	Intramuscular injections - single treatment session
BIOLOGICAL	Control medium	Intramuscular injections - single treatment session

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-07-01
• Completion: 2027-12-01
• First posted: 2016-06-17
• Last updated: 2025-06-06

Locations

5 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated drug study