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

Phase 1

Recruiting

• Conditions: Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease; Peripheral Vascular Disease
• Interventions: Biological: Control medium; Biological: BGC101 (autologous EnEPC preparation)

• Registration Number: NCT02805023
• Lead Sponsor: BioGenCell Ltd.

Brief 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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-11
• Last Update Posted: 2024-08-13
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Control medium	Intramuscular injection of control medium only
BGC101	BGC101 (autologous EnEPC preparation)	Intramuscular injection of BGC101 (autologous EnEPC preparation)

Primary Outcome Measures

Name	Time	Method
Safety (Incidence of adverse events)	12 Months	* Incidence and proportion of incidence between treatment arms of adverse events of specific interest (AESI) and injection-related AE; * Incidence of serious adverse events (SAEs) including SAEs related or probably related to the treatment; * Vital signs, physical examination, and electrocardiogram (ECG); * Safety laboratory values of hematology, blood chemistry, and urinalysis; * Local tolerability (injection site reaction)
Efficacy (Improvement of indication signs)	12 Months	* Major amputation (below or above the knee) rate at Month 12; * Major amputation-free survival (AFS) rate at Month 12

Trial Locations

Locations (5)

Laniado Hospital; 🇮🇱 Netanya, Israel

University of San Francisco; 🇺🇸 San Francisco, California, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Rambam Health Care Campus; 🇮🇱 Haifa, Israel