Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization

1. Non-atherosclerotic PAD (e.g. Buerger's disease).

2. CLI with major tissue loss (Rutherford Category 6) in either leg.

3. Evidence of active infection (e.g., cellulitis, osteomyelitis).

4. Subject having undergone surgical revascularization or major amputation less than 1 month prior to screening, or endovascular revascularization or minor amputation less than 2 weeks prior to screening.

5. Planned or potential need for major/minor amputation or any revascularization within 1 month of study entry upon investigator's judgment.

6. Aorto-iliac stenosis or common femoral artery stenosis ≥70%, or otherwise suspicion of inadequate inflow to the leg.

7. Life expectancy of less than 6 months.

8. Stroke or acute myocardial infarction/unstable angina within 3 months prior to screening.

9. Severe congestive heart failure symptoms (New York Heart Association \[NYHA\] class III-IV).

10. Uncontrolled severe hypertension.

11. Diabetes mellitus with HbA1c \>10%.

12. Current or history of proliferative retinopathy.

13. Known Hepatitis B virus or Hepatitis C virus or acquired immunodeficiency syndrome (AIDS) infections.

14. Subjects with international normalized ratio (INR) \>2.

15. Subject on renal replacement therapy or planned to start renal replacement therapy within 3 months of first screening visit.

16. Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending another investigational device or drug trial(s), unless in long-term follow-up phase.

17. Use of hyperbaric oxygen therapy, prostanoids, spinal cord stimulation, lumbar sympathectomy, wound dressing containing cells or growth factors, or topical platelet derived growth factor.

18. Known allergies to any of the following: DMSO, human serum albumin, bovine serum albumin.

19. History of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with IV steroids/epinephrine.

20. Pulmonary disease requiring supplemental oxygen treatment on a daily basis.

21. Active malignancy or history of malignancy within 5 years prior to study entry.

22. In the opinion of the investigator, the subject is unsuitable for participating in the study.

23. Chronic liver disease Child Pugh class B\\C

What this study is about