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

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.

Conditions

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

Interventions

BIOLOGICAL

BGC101 (autologous EnEPC preparation)

Intramuscular injections - single treatment session

BIOLOGICAL

Control medium

Intramuscular injections - single treatment session

Sponsors & Collaborators

• Laniado Hospital

  collaborator OTHER

• Rabin Medical Center

  collaborator OTHER

• BioGenCell Ltd.

  lead INDUSTRY

Principal Investigators

• Shlomo J Baytner, MD · Director of Vascular Surgery, Laniado Hospital, IL

• Michael Conte, MD · University of California, San Francisco - Division Vascular and Endovascular surgery

• Edouard Aboian, MD · Yale University School of Medicine- Division of Vascular Surgery, Department of Surgery

• Caitlin Hicks, MD · Division of Vascular Surgery and Endovascular Therapy, Johns Hopkins Hospital

• Tony Karram, MD · Director Department of Vascular Surgery & Transplantation Rambam Health Care Campus - IL

• Nathalie Moreels, MD · University Hospital Ghent-Thoracale en vasculaire heelkunde

• Jeffrey J Siracuse, MD · Boston Medical Center

• Khanjan Nagarsheth, MD · University of Maryland

• Paata Meshveliani, MD · West Georgia Medical Center (Kutaisi Hospital)

• Moshe Halak, MD · The Sheba Fund for Health Services and Research, Sheba Medical Center at Tel HaShomer

• Igor Laskowski, MD · New York Medical College ("NYMC") and Westchester County Health Care Corporation, operator of Westchester Medical Center.

• Mark Wyers, MD · Beth Israel Deaconess Medical Center (Harvard-Boston)

• Alisha Oropallo, MD · Northwell Health

• Alexander Reyzelman, MD · Center for Clinical Research Castro Valley- Main site Post Street -Satellite site

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2017-07-31

Completion

2027-12-31

FDA Drug

Yes

Countries

• United States
• Israel

Study Locations