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

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ClinicalTrials.gov Identifier: NCT02805023
Recruitment Status : Recruiting
First Posted : June 17, 2016
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
Laniado Hospital
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase 1/2, Open Label & Randomized Placebo Controlled Study to Assess the Feasibility of BGC101 (EnEPC) in the Treatment of Peripheral Arterial Disease (PAD) With Critical Limb Ischemia (CLI)
Study Start Date : June 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02805023


Contacts
Contact: Dikla Varsano, LL.B., RN dvarsano@laniado.org.il
Contact: Odelia Shmulevitz, MSc oshmulevitz@laniado.org.il

Locations
Israel
Laniado Hospital Recruiting
Netanya, Israel, 42150
Contact: Dikla Varsano, LL.B., RN    . +972-(0)9-8925248    dvarsano@laniado.org.il   
Contact: Odelia Shmulevitz, MsC    +972-(0)9-8925248    oshmulevitz@laniado.org.il   
Sponsors and Collaborators
BioGenCell Ltd.
Laniado Hospital
Investigators
Principal Investigator: Mark J Niven, MA.MB.BChir.FRCP Director of Bildirici Diabetes Center, Laniado Hospital, IL

Publications:
Responsible Party: BioGenCell Ltd.
ClinicalTrials.gov Identifier: NCT02805023     History of Changes
Other Study ID Numbers: BioGenCell Ltd
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Ischemia
Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases