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

Study Overview
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Brief Summary
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Allogenic platelet lysate will be injected in the gastrocnemius of patients with peripheral arterial disease (PAD)

Detailed Description
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Allogenic platelet rich plasma (PRP) will be collected from blood group AB donors. This plasma will be tested for the presence of any chronic infectious blood borne disease. Platelet lysate will be then prepared from the tested PRP to be intramuscularly injected in patients with PAD

Official Title
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A Randomized, Double Blind, Placebo Controlled Trial, Investigating the Effect of Intramuscular Injection of Allogenic Platelet Lysate for the Treatment of PAD

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Biological: Platelet lysate
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Platelet lysate<br>A total of 5 ml platelet lysate will be intramuscularly injected in 4 doses with 2 week interval | Biological: Platelet lysate<br>* Intramuscular injection of platelet lysate<br>|
| Placebo Comparator: placebo<br>A total of 5 ml of Normal Saline will be intramuscularly injected in 4 doses with 2 week interval | Biological: Placebo<br>* intramuscular injection of normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Frequency and nature of adverse events occurring during a 6-month period following platelet lysate injection(s). This will be assessed by physical examination combined with a report with chemistry blood tests. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the preliminary efficacy of the platelet lysate injection on patients' ABI | Positive changes in patients' Ankle brachial index (ABI) | 12 months | 
| Evaluation of the preliminary efficacy of the platelet lysate injection on patients' Toe pressure | Positive changes in patients' Toe pressure (mm Hg) | 12 months | 
| Evaluation of the preliminary efficacy of the platelet lysate injection on patients' TcPO2 | Positive changes in patients' Transcutaneous oxygen pressure (TcPO2) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral arterial disease, Platelet lysate