Assessing the Feasibility of BGC101 in the Treatment of PAD & CLI

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).

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