Use of Allogenic Platelet Lysate in Peripheral Arterial Disease (PAD)

• Competent and willing to give informed consent, and to be available for all baseline treatment and follow up examinations required by the protocol.
• Gender: Male or female.
• Age group > 50 years.
• Established Critical limb ischemia (CLI), clinically and hemodynamically confirmed as per Rutherford 3, 4 and 5 with angiographic evidence of significant infra-inguinal arterial occlusive disease.
• History of intermittent claudication for > eight weeks.
• Limited exercise due to moderate to severe claudication.
• Resting ABI \< 0.6, toe pressure ≤ 60 mm Hg, Toe Brachial index (TBI) \<0.6, or TcPO2 ≤ 60 mmHg in the foot.
• Not eligible for surgical or radiological revascularization, and doesn't respond to best standard care delivered as confirmed by a vascular surgeon and/or physician.
• Fairly controlled diabetes (Hemoglobin A1c \<10%).
• Normal liver enzymes, serum creatinine \< 1.4
• Normal platelet count.
• On regular medication for hypertension if any.
• No evidence of malignancy
• Body mass index \<30.

Exclusion Criteria:

• Women with child bearing potential, pregnant and lactating women.
• Rheumatoid Arthritis.
• History of neoplasm or malignancy in the past 10 years.
• Reported unstable cardiovascular disease, heart failure or symptomatic postural hypotension within 6 months before screening.
• Leg edema
• Inflammatory or progressive fibrotic disorder
• Renal insufficiency or failure
• History of infectious disorder (Human immunodeficiency virus (HIV) and/or hepatitis viruses).
• Chronic inflammatory disease
• History of stroke or myocardial infarction (\< 3 months).
• Bleeding or clotting disorder, use of oral anticoagulant therapy (heparin, warfarin).