Treatment of PAD by Platelet Lysate for Therapeutic Angiogenesis

Safety and Efficacy of Platelet Lysate for Therapeutic Angiogenesis in Patients With Peripheral Arterial Disease

Induction of autologous angiogenesis in patients with critical limb ischemia using platelet lysate.

Study Overview

• Status: Completed
• Conditions: Critical Limb Ischemia
• Intervention / Treatment: Biological: Platelet lysate

Detailed Description

Ten male and female patients diagnosed with Peripheral artery disease (PAD), will be recruited. This diagnosis will be based on medical history, physical examinations, laboratory tests, and specific diagnostic tests. Patients qualified for this study, are patients with distal extremity ischemia indicated by claudication and rest pain present for a minimum of 4 weeks without evidence of improvement in response to conventional drug therapy; showed angiographic evidence of PAD in the affected limb; and were not candidates for surgical revascularization. Platelet lysate will be injected intramuscularly at different sites of the gastrocnemius muscle. The purpose of this study is to evaluate the safety and efficacy of platelet lysate injections into ischematic limbs of patients with PAD.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
• Established Peripheral arterial disease, clinically and hemodynamically confirmed as per Rutherford 3, 4 and
• History of intermittent claudication for > eight weeks.
• Limited exercise due to moderate to severe claudication.
• Resting ankle brachial index (ABI) < 0.85, toe pressure ≤ 60 mm Hg, Toe brachial index (TBI) <0.6, or Trans-cutaneous oxygen pressure (TcPO2) ≤ 60 mmHg in the foot.
• Not eligible for surgical or radiological revascularization.
• In case of diabetic patients, he/she should be on medication and fairly controlled (HbA1c <10%).
• Normal liver enzymes, serum creatinine < 1.4
• Normal platelet count.
• On regular medication for hypertension if any.
• No evidence of malignancy
• Low Questionnaire scores.
• 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.
• Chronic inflammatory disease
• History of stroke or myocardial infarction ( < 3 months).
• Bleeding or clotting disorder, use of oral anticoagulant therapy (heparin, warfarin).
• Lab values for
• Hemoglobin <10 g/dl.
• Platelet count <100,000.
• Prothrombin time/ partial thromboplastin time (PT/PTT)> 3 seconds.
• Alanine aminotrasferase (ALT) and aspartatet aminotrasferase (AST) > 1.5x of the normal lab value.
• Creatinine ≥ 1.4
• Poorly controlled diabetes (HbA1c ≥10)
• Bilirubin > 1.5x of the normal lab value.
• Systemic autoimmune disease.
• Receiving immunosuppressant medications.
• Uncontrolled hypertension or hypotension.
• Abdominal aortic aneurism > 5 cm.
• Active or untreated Tuberculosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet lysate injection; Injection of platelet lysate intramuscularly in the gastrocnemius muscle	Biological: Platelet lysate; Autologous intramuscular platelet lysate injection for patients with peripheral arterial disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment the safety of platelet lysate injection	Patients will be assessed for any relevant adverse event resulting from the platelet lysate injection	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment the efficacy of platelet lysate injection	Assessing the therapeutic benefit of all four platelet lysate injections by ankle brachial index (ABI).	6 months

Collaborators and Investigators

• Sponsor: University of Jordan

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2013
• Primary Completion (Actual): September 15, 2016
• Study Completion (Actual): February 9, 2017

Study Registration Dates

• First Submitted: October 19, 2016
• First Submitted That Met QC Criteria: October 20, 2016
• First Posted (Estimate): October 21, 2016

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Peripheral arterial disease; Critical limb ischemia; Platelet lysate
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Ischemia; Peripheral Arterial Disease
• Other Study ID Numbers: PADUJCTC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No