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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)
EU CTIS ID: 2024-516665-36-00
What this study is testing
To evaluate the feasibility, safety and efficacy of BGC101 in the treatment of patients suffering from PAD with CLI, who have not responded to the standard of care (SOC) including prior limb revascularization and do not have the option of further revascularization treatment.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female patient 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): • Toe pressure <40 mmHg • Ankle pressure <70 mmHg • TcPO2 < 40mmHg
You likely can't join if
- Severe, uncorrected aorto-iliac and/or common femoral artery disease, i.e. absent femoral pulse or monophasic common femoral artery Doppler waveform
- 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)
See the full eligibility criteria
- Male or female patient 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): • Toe pressure <40 mmHg • Ankle pressure <70 mmHg • TcPO2 < 40mmHg
- Meeting one of the following conditions: a. 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. b. After undergoing clinically ineffective revascularization. c. Four weeks or more after a revascularization failure
- Severe, uncorrected aorto-iliac and/or common femoral artery disease, i.e. absent femoral pulse or monophasic common femoral artery Doppler waveform
- 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], gammaglutamyl transferase [GGT], lactate dehydrogenase [LDH])
- Abnormal coagulation tests when not under warfarin (normalized prothrombin time [PT INR] >2)
- Concurrent therapy that, in the Investigator’s opinion, would interfere with the evaluation of the feasibility of the study medication
- 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
- 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Georgia
- Israel
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Georgia; Israel; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.