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

June 5, 2025 updated by: BioGenCell Ltd.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Rambam Health Care Campus
      • Netanya, Israel, 42150
        • Laniado Hospital
  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of San Francisco
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8039
        • Yale University School of Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. Able to complete the study and comply with instructions.
  2. Capable of understanding the purpose of the study and the contents of the informed consent form.
  3. Aged at least 18 years.
  4. Non-pregnant and non-lactating female patients.
  5. Have the clinical indications diagnostic of CLI based on Rutherford category 4-5

  6. Have at least one of the hemodynamic indicators of severe peripheral arterial occlusive disease (WIfI ischemia grade 2):

    • Toe pressure < 40 mmHg
    • Ankle pressure < 70 mmHg
    • TcPO2 < 40mmHg

  7. Meeting one of the following conditions:

    1. Poor candidate for standard revascularization treatment for peripheral arterial disease due to unfavorable anatomy or high surgical/intervention risk based on the patient's underlying comorbidities.

    2. After undergoing clinically ineffective revascularization. Six weeks or more after undergoing a prior index limb revascularization the patient demonstrates:

      • No improvement in clinical signs and symptoms of CLI as evidenced by lack of improvement in rest pain (when not under increased pain relief) and/or inadequate wound healing or progression of tissue loss despite adequate standard treatment.
      • Ongoing ischemia as defined above in the inclusion criterion 6.
      • The patient is no longer amenable to further interventional or surgical revascularization (see inclusion criterion 7c below).

    3. Four weeks or more after a revascularization failure.

      • Technical Failure of the revascularization (inability to successfully cross or treat the intended target arterial path, thrombosis of the bypass graft or treated artery within 7 days of procedure)
      • Hemodynamic Failure of the revascularization (lack of improvement in toe pressure, ankle pressure, or TcPO2) post-procedure

Exclusion criteria:

  1. Severe uncorrected aorto-iliac and/or common femoral artery disease, absent of femoral pulse or monophasic common femoral artery Doppler waveform.
  2. Concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the feasibility of the study medication.
  3. Treatment with any investigational product within the last 6 months or enrollment in any active study involving the use of investigational devices or drugs.
  4. Presence of any other condition or circumstance that, in the judgment of the investigator, might negatively impact the outcomes of the treatment under investigation.
  5. Prognosis of a major amputation (below or above the knee), within 4 weeks after screening.
  6. Severe wound (WIfI wound grade 2 or 3).
  7. Significant ongoing infection (WIfI infection grade 2 or 3).
  8. Relative or absolute contraindications for intramuscular injections at the intended treatment site, in cases such as severe skin lesions, severe edema or morbid obesity, based on clinician opinion.
  9. Patient suffering from active vasculitis
  10. Blood transfusions during the preceding 4 weeks (to exclude the potential of non-autologous cells in the harvested blood).
  11. Hemoglobin (Hb) less than 9 g/dL.
  12. Patient with HbA1C > 8.5%
  13. Myocardial infarction, cerebral infarction , uncontrolled myocardial ischemia or persistent severe heart failure (ejection fraction [EF] < 25%) during the preceding 3 months.
  14. Heart failure (New York Heart Association [NYHA] 3-4).
  15. Significant valvular disease or less than 4 weeks after valve replacement or repair
  16. Renal failure (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m², chronic kidney damage stage 4-5).
  17. Liver failure, Model for End-stage Liver Disease (MELD) scores 15 and higher.
  18. Liver function tests more than three times normal upper limit (normal limits being defined in each local laboratory) (glutamic-oxaloacetic transaminase [GOT], glutamic-pyruvic transaminase [GPT], alkaline phosphatase [AlkP], gamma-glutamyl transferase [GGT], lactate dehydrogenase [LDH]).
  19. Abnormal coagulation tests when not under warfarin (normalized prothrombin time [PT INR] >2).
  20. Pregnant or lactating women at entry of study.
  21. People who are unwilling to agree to use acceptable methods of contraception during the study.
  22. Malignancy within the preceding 3 years, except basal cell carcinoma.
  23. Concurrent acute infectious disease with septicemia
  24. Chronic infectious disease (human immunodeficiency virus-1 [HIV-1], human immunodeficiency virus-2 [HIV-2], hepatitis B virus [HBV], hepatitis C virus [HCV]).
  25. Immunodeficiency syndrome.
  26. Raynaud's syndrome
  27. Systemic treatment with cytotoxic and/or immunosuppressive treatment.
  28. Inability to communicate (that may interfere with the clinical evaluation of the patient).
  29. Patient unlikely to be available for follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Intramuscular injection of control medium only
Biological: Control medium
Intramuscular injections - single treatment session
Experimental: BGC101
Intramuscular injection of BGC101 (autologous EnEPC preparation)
Biological: BGC101 (autologous EnEPC preparation)
Intramuscular injections - single treatment session

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety (Incidence of adverse events)
Time Frame: 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)
12 Months
Efficacy (Improvement of indication signs)
Time Frame: 12 Months
  • Major amputation (below or above the knee) rate at Month 12
  • Major amputation-free survival (AFS) rate at Month 12
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioGenCell Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rabin Medical Center
Laniado Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shlomo J Baytner, MD, Director of Vascular Surgery, Laniado Hospital, IL
  • Principal Investigator: Alisha Oropallo, MD, Northwell Health
  • Principal Investigator: Jeffrey J Siracuse, MD, Boston Medical Center
  • Principal Investigator: Michael Conte, MD, University of California, San Francisco - Division Vascular and Endovascular surgery
  • Principal Investigator: Edouard Aboian, MD, Yale University School of Medicine- Division of Vascular Surgery, Department of Surgery
  • Principal Investigator: Caitlin Hicks, MD, Division of Vascular Surgery and Endovascular Therapy, Johns Hopkins Hospital
  • Principal Investigator: Tony Karram, MD, Director Department of Vascular Surgery & Transplantation Rambam Health Care Campus - IL
  • Principal Investigator: Nathalie Moreels, MD, University Hospital Ghent-Thoracale en vasculaire heelkunde
  • Principal Investigator: Khanjan Nagarsheth, MD, University of Maryland
  • Principal Investigator: Paata Meshveliani, MD, West Georgia Medical Center (Kutaisi Hospital)
  • Principal Investigator: Moshe Halak, MD, The Sheba Fund for Health Services and Research, Sheba Medical Center at Tel HaShomer
  • Principal Investigator: Igor Laskowski, MD, New York Medical College ("NYMC") and Westchester County Health Care Corporation, operator of Westchester Medical Center.
  • Principal Investigator: Mark Wyers, MD, Beth Israel Deaconess Medical Center (Harvard-Boston)
  • Principal Investigator: Alexander Reyzelman, MD, Center for Clinical Research Castro Valley- Main site Post Street -Satellite site

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BioGenCell Ltd

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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