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

Sophia Al-Adwan

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Peripheral Arterial Disease

Treatments: Biological: Placebo; Biological: Platelet lysate

Study type: Interventional

Funder types: Other

Identifiers

NCT03297814

PAD2UJCTC

Details and patient eligibility

About

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

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

20 participants in 2 patient groups, including a placebo group

Platelet lysate

Active Comparator group

Description:

A total of 5 ml platelet lysate will be intramuscularly injected in 4 doses with 2 week interval

Treatment:

Biological: Platelet lysate

placebo

Placebo Comparator group

Description:

A total of 5 ml of Normal Saline will be intramuscularly injected in 4 doses with 2 week interval

Treatment:

Biological: Placebo