COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Assessing the Feasibility of BGC101 in the Treatment of PAD & CLI (EnEPC-CLI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02805023
Recruitment Status : Active, not recruiting
First Posted : June 17, 2016
Last Update Posted : January 27, 2020
Laniado Hospital
Rabin Medical Center
University of Liege
Information provided by (Responsible Party):
BioGenCell Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Peripheral Arterial Disease Peripheral Vascular Disease Biological: BGC101 (autologous EnEPC preparation) Biological: Control medium Phase 1 Phase 2

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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1/2, Double Blind Randomized Placebo Controlled Study to Assess the Safety and Efficacy of BGC101 (EnEPC) in the Treatment of PAD & CLI
Study Start Date : June 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Safety (Evaluation of adverse events - lack of severe adverse events) [ Time Frame: Six months ]
    Evaluation of adverse events - lack of severe adverse events

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  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:

    • Clinical assessment as Rutherford 4-5
    • Rest pain
    • Non-healing ischemic ulcers
    • Minor tissue loss
  5. At least one of the hemodynamic indicators of severe peripheral arterial occlusive disease:

    • Ankle brachial index (ABI) <0.45
    • Toe brachial index (TBI) <0.4
    • TcPO2 < 40mmHg
    • 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).

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02805023

Layout table for location information
Laniado Hospital
Netanya, Israel, 42150
Sponsors and Collaborators
BioGenCell Ltd.
Laniado Hospital
Rabin Medical Center
University of Liege
Layout table for investigator information
Principal Investigator: Mark J Niven, MABChirFRCP Director of Bildirici Diabetes Center, Laniado Hospital, IL
Layout table for additonal information
Responsible Party: BioGenCell Ltd. Identifier: NCT02805023    
Other Study ID Numbers: BioGenCell Ltd
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Cardiovascular Diseases
Arterial Occlusive Diseases