Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

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.

Official Title

Phase 1/2, Open Label & Double Blind Randomized Placebo Controlled Study to Assess the Safety and Efficacy of BGC101 (EnEPC) in the Treatment of PAD With CLI

Details

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.

Keywords

Critical Limb Ischemia Peripheral Arterial Disease Peripheral Vascular Disease Vascular Diseases Peripheral Vascular Diseases Ischemia BGC101 (autologous EnEPC preparation) BGC101

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Have the time and ability 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. Age > 18 Male or non-pregnant, non-lactating female
  4. At least one of the clinical diagnostic indications of CLI:
  5. Clinical assessment as Rutherford 4-5
  6. Rest pain
  7. Non-healing ischemic ulcers
  8. Minor tissue loss
  9. At least one of the hemodynamic indicators of severe peripheral arterial occlusive disease:
  10. Ankle brachial index (ABI) <0.45
  11. Toe brachial index (TBI) <0.4
  12. TcPO2 < 40mmHg
  13. A poor candidate for standard revascularization treatment options for peripheral arterial disease due to (1) unfavorable anatomy (e.g. small vessel disease with no major vessel stenosis/obstruction) OR (2) continued presence of smaller vessel microvasculature) disease six weeks or more after revascularization (performed as part of standard care) based on patency of the treated vessel(s).

You CAN'T join if...

Patients who meet any of the following criteria are not eligible for this study.

  1. Concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
  2. Treatment with any investigational product within the last 6 months or enrollment in any active study involving the use of investigational devices or drugs.
  3. Presence of any other condition or circumstance that, in the judgment of the investigator, might increase the risk to the patient or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
  4. Based on clinician opinion - prognosis of a major amputation (below or above the knee) within 4 weeks from the assessment visit
  5. Lack of femoral artery blood flow
  6. Based on clinician opinion inability to perform intramuscular injections in cases such as sever skin lesions, severe edema or morbid obesity
  7. Blood transfusions during preceding 4 weeks (to exclude the potential of non-autologous cells in the harvested blood)
  8. Heart failure (NYHA 3-4)
  9. Hgb Less than 9gm
  10. . Myocardial infarction, brain infarction, uncontrolled myocardial ischemia or persistent severe heart failure (EF< 25 %) during the preceding 3 months
  11. . Significant valvular disease or after valve replacement (based on medical record)
  12. . Renal failure (eGFR <30, Chronic Kidney Damage Stage 4-5)
  13. . Liver function tests are more than three times normal upper limit (AST, ALT, ALP, GGT, LDH).
  14. . Abnormal coagulation tests (PT(INR) >2)
  15. . Pregnant or lactating women at entry to study
  16. . People who are unwilling to agree to use acceptable methods of contraception such as condom from screening during the study to prevent pregnancy and chronic infectious diseases (such as HIV-1,HIV-2, HBV, HCV)
  17. . Malignancy within the preceding 3 years, except for BCC
  18. . Concurrent acute infectious disease with septicemia
  19. . Chronic infectious diseases (HIV-1,HIV-2, Hepatitis viruses B and C)
  20. . Immunodeficiency syndrome
  21. . Cytotoxic drugs treatment
  22. . Inability to communicate (that may interfere with the clinical evaluation of the patient)
  23. . Patient unlikely to be available for follow-up

Locations

  • University of San Francisco
    San Francisco California 94143 United States
  • Laniado Hospital
    Netanya 42150 Israel

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BioGenCell Ltd.
ID
NCT02805023
Phase
Phase 1/2
Study Type
Interventional
Last Updated