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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03297814
• Other study ID #: PAD2UJCTC
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 18, 2018
• Est. completion date: May 2020

Study information

• Verified date: July 2019
• Source: University of Jordan
• Contact: Sofia Adwan, Msc
• Phone: 00962796175617
• Email: sophia.adwan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Biological:
• Platelet lysate
Intramuscular injection of platelet lysate
• Placebo
intramuscular injection of normal saline

Locations

Country	Name	City	State
Jordan	Cell Therapy Center	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Sophia Al-Adwan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of the preliminary efficacy of the platelet lysate injection on patients' ABI	Positive changes in patients' Ankle brachial index (ABI)	12 months
Secondary	Evaluation of the preliminary efficacy of the platelet lysate injection on patients' Toe pressure	Positive changes in patients' Toe pressure (mm Hg)	12 months
Secondary	Evaluation of the preliminary efficacy of the platelet lysate injection on patients' TcPO2	Positive changes in patients' Transcutaneous oxygen pressure (TcPO2)	12 months