AUTOLOGOUS BLOOD-DERIVED ENDOTHELIAL PROGENITOR CELLS, HAEMATOPOIETIC STEM/PROGENITOR CELLS, ACTIVATED DENDRITIC CELLS AND T HELPER CELLS for Peripheral arterial disease | Critical limb ischemia

Inclusion criteria

• {"criterion_text":"- Male or female patient able to complete the study and comply with instructions\n- Capable of understanding the purpose of the study and the contents of the informed consent form\n- Aged at least 18 years\n- Non-pregnant and non-lactating female patients\n- Have the clinical indications diagnostic of CLI based on Rutherford category 4-5\n- 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\n- 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"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- The primary safety endpoints will consist of: • 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 and physical examination • Safety laboratory values of hematology, blood chemistry, and urinalysis • Local tolerability (injection site reaction)","definition_or_measurement_approach":"Safety measured by incidence and proportion between treatment arms of AESIs and injection-related AEs; incidence of SAEs (including related/probably related); monitoring vital signs and physical examinations; laboratory tests (hematology, blood chemistry, urinalysis); assessment of local tolerability (injection site reaction)."}
• {"endpoint_text":"- The primary efficacy endpoints will consist of: • Major amputation (below or above the knee) rate at Month 12 • Major amputation-free survival (AFS) rate at Month 12","definition_or_measurement_approach":"Efficacy assessed by rate of major amputations (below or above the knee) at Month 12 and amputation-free survival (AFS) at Month 12."}

Belgium

Earliest CTIS Part Ii Submission Date

25-07-2024

Latest Decision Or Authorization Date

16-10-2024

Processing Time Days

83

Number Of Sites

1

Number Of Participants

5

Primary sponsor

Full Name

Biogencell Ltd.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Israel