Clinical trial NCT03297814: Use of Allogenic Platelet Lysate in Peripheral Arterial Disease (PAD)
Official title: A Randomized, Double Blind, Placebo Controlled Trial, Investigating the Effect of Intramuscular Injection of Allogenic Platelet Lysate for the Treatment of PAD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Peripheral Arterial Disease
Keywords: Peripheral arterial disease
Platelet lysate
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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).

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of the preliminary efficacy of the platelet lysate injection on patients' ABI
timeFrame: 12 months
measure: Evaluation of the preliminary efficacy of the platelet lysate injection on patients' Toe pressure
timeFrame: 12 months
measure: Evaluation of the preliminary efficacy of the platelet lysate injection on patients' TcPO2
timeFrame: 12 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Cell Therapy Center
Study officials:
affiliation: Cell Therapy Center
name: Abdalla Awidi, MD
role: STUDY_DIRECTOR
References: