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

• Adult male or female subjects between ages 45-99 years of age.

• CLI, with minor tissue loss up to the ankle level (Rutherford Category 5)

• Ankle pressure (AP) ≤70 mmHg or TP ≤50 mmHg in the index leg. (If a subject has ABI \>1.4 and TP is not measureable, inclusion may be based on TcPO2 ≤30 mmHg)

• Subject unsuitable for revascularization (by any method) in the index leg.

• Ischemic lesions in the index leg stable for at least 2 weeks.

• Ischemic ulcers in the index leg without tendon or bone exposure (unless secondary to a minor amputation).

• Under treatment for cardiovascular risk factors: hypertension, hyperlipidemia, diabetes, in accordance with applicable guidelines. Concomitant therapy with a statin and an anti-platelet agent for at least 2 weeks prior to randomization.

• Women of childbearing potential must have a negative serum pregnancy test at screening and must be willing to use at least one highly effective birth control method throughout the study.

• Subject understood, agreed and provided informed consent. Patients must give written informed consent before any assessment is performed .