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Clinical trialNCT02805023Active, not recruitingPhase 1/PHASE2Interventional

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

SponsorBioGenCell Ltd.Enrollment40Chronic Limb-Threatening IschemiaPeripheral Arterial DiseasePeripheral Vascular Disease
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Alexander Reyzelman, MD

    Center for Clinical Research Castro Valley- Main site Post Street -Satellite site

    Principal Investigator
  • Alisha Oropallo, MD

    Northwell Health

    Principal Investigator
  • Caitlin Hicks, MD

    Division of Vascular Surgery and Endovascular Therapy, Johns Hopkins Hospital

    Principal Investigator
  • Edouard Aboian, MD

    Yale University School of Medicine- Division of Vascular Surgery, Department of Surgery

    Principal Investigator
  • Igor Laskowski, MD

    New York Medical College ("NYMC") and Westchester County Health Care Corporation, operator of Westchester Medical Center.

    Principal Investigator
  • Jeffrey J Siracuse, MD

    Boston Medical Center

    Principal Investigator
  • Khanjan Nagarsheth, MD

    University of Maryland

    Principal Investigator
  • Mark Wyers, MD

    Beth Israel Deaconess Medical Center (Harvard-Boston)

    Principal Investigator
  • Michael Conte, MD

    University of California, San Francisco - Division Vascular and Endovascular surgery

    Principal Investigator
  • Moshe Halak, MD

    The Sheba Fund for Health Services and Research, Sheba Medical Center at Tel HaShomer

    Principal Investigator
  • Nathalie Moreels, MD

    University Hospital Ghent-Thoracale en vasculaire heelkunde

    Principal Investigator
  • Paata Meshveliani, MD

    West Georgia Medical Center (Kutaisi Hospital)

    Principal Investigator
  • Shlomo J Baytner, MD

    Director of Vascular Surgery, Laniado Hospital, IL

    Principal Investigator
  • Tony Karram, MD

    Director Department of Vascular Surgery & Transplantation Rambam Health Care Campus - IL

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Israel
  • Rambam Health Care Campus

    Haifa, Israel

  • Laniado Hospital

    Netanya, Israel

United States
  • University of San Francisco

    San Francisco, California, United States

  • Yale University School of Medicine

    New Haven, Connecticut, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

BGC101Control medium
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Jun 2016
Primary completion
31 Jul 2017
Completion
31 Dec 2027
Last update posted
6 Jun 2025
Registered enrollment
40
Registry id
NCT02805023

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.