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ACTIVE NOT RECRUITING Phase 1

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

NCT02805023 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • BIOLOGICAL BGC101 (autologous EnEPC preparation)
  • BIOLOGICAL Control medium

Study Locations (5)

Other

  • Rambam Health Care Campus — Haifa
  • Laniado Hospital — Netanya

California

  • University of San Francisco — San Francisco

Connecticut

  • Yale University School of Medicine — New Haven

Maryland

  • Johns Hopkins Hospital — Baltimore

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2016-06
Est. Completion 2027-12
Phase Phase 1

Sponsor

BioGenCell

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02805023

The ClinicalTrials.gov registry entry for NCT02805023 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioGenCell, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 2 interventions — of which BGC101 (autologous EnEPC preparation) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02805023 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Other, California, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02805023 about?

NCT02805023 is a clinical study titled "BGC101 (EnEPC) Autologous Cell Therapy From Patient's Own Blood for Treatment of Critical Limb Ischemia (CLI)". 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 c...

What is the current status of trial NCT02805023?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2016-06. Estimated completion is 2027-12.

What conditions does trial NCT02805023 study?

This clinical trial studies the following conditions: Peripheral Arterial Disease, Peripheral Vascular Disease, Chronic Limb-Threatening Ischemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02805023?

The interventions under investigation include: BGC101 (autologous EnEPC preparation) (BIOLOGICAL), Control medium (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02805023?

This trial is sponsored by BioGenCell, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02805023 being conducted?

This trial has 5 study locations across California, Connecticut, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial