Treatment of PAD by Platelet Lysate for Therapeutic Angiogenesis

NCT02941419 | Completed Phase 1

• 1 other identifier: PADUJCTC
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Critical Limb Ischemia

Keywords

Platelet lysate; Critical limb ischemia; Peripheral arterial disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment the efficacy of platelet lysate injection

  6 months

Study Arms (1)

Platelet lysate injection

EXPERIMENTAL

Injection of platelet lysate intramuscularly in the gastrocnemius muscle

Biological: Platelet lysate

Interventions

Platelet lysate BIOLOGICAL

Autologous intramuscular platelet lysate injection for patients with peripheral arterial disease

Platelet lysate injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jordan: lead

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 21, 2016
• Study Start: March 5, 2013
• Primary Completion: September 15, 2016
• Study Completion: February 9, 2017
• Last Updated: May 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share