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

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

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

Study Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Biological: Platelet lysate; Biological: Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan, 11942
    • Recruiting
    • Cell Therapy Center
    • Contact: Sofia Adwan, PhD; Phone Number: 23960 962-6-5355000; Email: sophia.adwan@gmail.com
    • Contact: hanan Jafar, PhD; Phone Number: 23960 00962-6-5355000; Email: hanan.jafar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 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.
• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Platelet lysate; A total of 5 ml platelet lysate will be intramuscularly injected in 4 doses with 2 week interval	Biological: Platelet lysate; Intramuscular injection of platelet lysate
PLACEBO_COMPARATOR: placebo; A total of 5 ml of Normal Saline will be intramuscularly injected in 4 doses with 2 week interval	Biological: Placebo; intramuscular injection of normal saline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sophia Al-Adwan

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 18, 2018
• Primary Completion (ANTICIPATED): March 1, 2020
• Study Completion (ANTICIPATED): May 1, 2020

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (ACTUAL): September 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Peripheral arterial disease; Platelet lysate
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: PAD2UJCTC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No