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Chronic Limb-Threatening IschemiaPhase 1/2EnEPC-CLINCT02805023

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

A Phase 1/2 study testing BGC101 (autologous EnEPC preparation) in people with Chronic Limb-Threatening Ischemia and Peripheral Arterial Disease, run by BioGenCell Ltd. at 5 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BGC101 (autologous EnEPC preparation)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
5 sitesin 2 countries
Study dates
Jun 2016to Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to complete the study and comply with instructions.
  • Capable of understanding the purpose of the study and the contents of the informed consent form.
  • Aged at least 18 years.
  • Non-pregnant and non-lactating female patients.
  • Have the clinical indications diagnostic of CLI based on Rutherford category 4-5
  • Have at least one of the hemodynamic indicators of severe peripheral arterial occlusive disease (WIfI ischemia grade 2):
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  • Toe pressure < 40 mmHg
  • Ankle pressure < 70 mmHg
  • TcPO2 < 40mmHg
  • Meeting one of the following conditions:
  • 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.
  • 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).
  • 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

Who cannot join

  • Severe uncorrected aorto-iliac and/or common femoral artery disease, absent of femoral pulse or monophasic common femoral artery Doppler waveform.
  • Concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the feasibility of the study medication.
  • Treatment with any investigational product within the last 6 months or enrollment in any active study involving the use of investigational devices or drugs.
  • Presence of any other condition or circumstance that, in the judgment of the investigator, might negatively impact the outcomes of the treatment under investigation.
  • Prognosis of a major amputation (below or above the knee), within 4 weeks after screening.
  • Severe wound (WIfI wound grade 2 or 3).
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  • Significant ongoing infection (WIfI infection grade 2 or 3).
  • 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.
  • Patient suffering from active vasculitis
  • Blood transfusions during the preceding 4 weeks (to exclude the potential of non-autologous cells in the harvested blood).
  • Hemoglobin (Hb) less than 9 g/dL.
  • Patient with HbA1C > 8.5%
  • Myocardial infarction, cerebral infarction , uncontrolled myocardial ischemia or persistent severe heart failure (ejection fraction [EF] < 25%) during the preceding 3 months.
  • Heart failure (New York Heart Association [NYHA] 3-4).
  • Significant valvular disease or less than 4 weeks after valve replacement or repair
  • Renal failure (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m², chronic kidney damage stage 4-5).
  • Liver failure, Model for End-stage Liver Disease (MELD) scores 15 and higher.
  • 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]).
  • Abnormal coagulation tests when not under warfarin (normalized prothrombin time [PT INR] >2).
  • Pregnant or lactating women at entry of study.
  • People who are unwilling to agree to use acceptable methods of contraception during the study.
  • Malignancy within the preceding 3 years, except basal cell carcinoma.
  • Concurrent acute infectious disease with septicemia
  • Chronic infectious disease (human immunodeficiency virus-1 [HIV-1], human immunodeficiency virus-2 [HIV-2], hepatitis B virus [HBV], hepatitis C virus [HCV]).
  • Immunodeficiency syndrome.
  • Raynaud's syndrome
  • Systemic treatment with cytotoxic and/or immunosuppressive treatment.
  • Inability to communicate (that may interfere with the clinical evaluation of the patient).
  • Patient unlikely to be available for follow-up.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

United States3 sites

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Yale University School of Medicine

    New Haven, Connecticut, 06520-8039

  • University of San Francisco

    San Francisco, California, 94143

Other trials in United States

Israel2 sites

  • Rambam Health Care Campus

    Haifa, 31096

  • Laniado Hospital

    Netanya, 42150

Other trials in Israel

About this study

Official title: 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.

Read the 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.

Being tested
BGC101 (autologous EnEPC preparation), Control medium
Medical subject headings
Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BGC101 (autologous EnEPC preparation)Biological

    Intramuscular injections - single treatment session

  • Control mediumBiological

    Intramuscular injections - single treatment session

Study groups in NCT02805023
Study groupRoleWhat they receive
PlaceboPlacebo comparatorIntramuscular injection of control medium only
Receives: Biological: Control medium
BGC101ExperimentalIntramuscular injection of BGC101 (autologous EnEPC preparation)
Receives: Biological: BGC101 (autologous EnEPC preparation)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety (Incidence of adverse events)

    • 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)

    Measured: 12 Months

  2. Efficacy (Improvement of indication signs)

    • Major amputation (below or above the knee) rate at Month 12
    • Major amputation-free survival (AFS) rate at Month 12

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJul 2017
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02805023
Sponsor's protocol ID
BioGenCell Ltd
Acronym
EnEPC-CLI
Status last verified
Jun 2025
First submitted
15 Jun 2016
Last updated
6 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Porat Y, Assa-Kunik E, Belkin M, Krakovsky M, Lamensdorf I, Duvdevani R, Sivak G, Niven MJ, Bulvik S. A novel potential therapy for vascular diseases: blood-derived stem/progenitor cells specifically activated by dendritic cells. Diabetes Metab Res Rev. 2014 Oct;30(7):623-34. doi: 10.1002/dmrr.2543.

    PubMed 24638886

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BGC101 (autologous EnEPC preparation) in people with Chronic Limb-Threatening Ischemia and Peripheral Arterial Disease, run by BioGenCell Ltd. at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (Incidence of adverse events) (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02805023, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.

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