Study of HGF Via Plasmid Vector to Improve Perfusion in Critical Limb Ischemia

Inclusion Criteria:

• Subjects will have one or more clinical indications diagnostic of CLI such as: distalextremity pain at rest that requires the subject to use analgesics for >2 weeks; orperipheral ischemic ulcer(s); or areas of gangrene.

• The subject will have a TcPO2 of </= 40 mmHg.

• Subjects will have one or both of the following hemodynamic indicators of severeperipheral arterial occlusive disease: (a) Ankle systolic pressure of </= 70 mmHg; (b)Toe systolic pressure </= 50 mmHg.

• The subject is a poor candidate for standard revascularization treatment options forperipheral arterial disease, based on inadequate bypass conduit, unfavorable anatomy,or poor operative risk.

• Subject has signed an informed consent form either directly or through a legallyauthorized representative

• If female, the subject must be (a) at least one year post-menopausal, or (b)surgically sterile, or (c) if the subject is of child-bearing potential, she must havebeen practicing contraception for at least 12 weeks prior to entering the study.

• If subject is of reproductive potential, he or she must be using an accepted andeffective (barrier) form of birth control during the study.

• Subjects will be on a statin and an anti-platelet agent as part of their standard ofcare and must be stable on these regimens for at least 4 weeks prior to treatment.

Exclusion Criteria:

• Subjects, who in the opinion of the investigator, have a vascular disease prognosisthat indicates they would require a major amputation (at or above the ankle) within 4weeks of start of treatment.

• Subjects with a diagnosis of Buerger's disease (Thromboangitis Obliterans).

• Subjects with hemodynamically significant aorto-iliac occlusive disease.

• Subjects who have had a revascularization procedure within 12 weeks prior to treatmentinitiation that remains patent. Revascularization procedures that are evidenced tohave failed for >2 weeks prior to treatment initiation are acceptable.

• Subjects who require a change in their hypertension medication as part of theirstandard of care within 4 weeks prior to treatment.

• Evidence or history of malignant neoplasm (clinical, laboratory or imaging), exceptfor basal cell carcinoma of the skin.

• Subjects who have proliferative diabetic retinopathy or severe, non-proliferativeretinopathy

• Subjects with end stage renal disease (ESRD) defined as significant renal dysfunctionevidenced by a creatinine of > 2.5, or receiving chronic hemodialysis therapy.

• A subject who has hepatic cirrhosis, viral hepatitis, or is HIV positive.

• Subjects with a clinically significant liver enzyme abnormality (i.e., AST or ALT morethan two times the upper limit of normal and/or bilirubin more than 50% the upperlimit of normal).

• Subjects requiring the use of hyperbaric oxygen treatment for wound healing during thescreening and 6 month follow-up period.