Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization

Pluristem Ltd.57 sites in 7 countries213 target enrollmentMay 22, 2017

ConditionsCritical Limb Ischemia (CLI)

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Critical Limb Ischemia (CLI)
Sponsor: Pluristem Ltd.
Enrollment: 213
Locations: 57
Primary Endpoint: Time to major amputation or death (AFS)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This will be a randomized, placebo-controlled, parallel group, multicenter, Phase III study.The study aims to evaluate the Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects with Critical Limb Ischemia (CLI) with Minor Tissue Loss (Rutherford Category 5) who are Unsuitable for Revascularization.

Registry

clinicaltrials.gov

Start Date

May 22, 2017

End Date

April 20, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pluristem Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult male or female subjects between ages 45-99 years of age.
•CLI, with minor tissue loss up to the ankle level (Rutherford Category 5)
•Ankle pressure (AP) ≤70 mmHg or TP ≤50 mmHg in the index leg. (If a subject has ABI \>1.4 and TP is not measureable, inclusion may be based on TcPO2 ≤30 mmHg)
•Subject unsuitable for revascularization (by any method) in the index leg.
•Ischemic lesions in the index leg stable for at least 2 weeks.
•Ischemic ulcers in the index leg without tendon or bone exposure (unless secondary to a minor amputation).
•Under treatment for cardiovascular risk factors: hypertension, hyperlipidemia, diabetes, in accordance with applicable guidelines. Concomitant therapy with a statin and an anti-platelet agent for at least 2 weeks prior to randomization.
•Women of childbearing potential must have a negative serum pregnancy test at screening and must be willing to use at least one highly effective birth control method throughout the study.
•Subject understood, agreed and provided informed consent. Patients must give written informed consent before any assessment is performed .

Exclusion Criteria

•Non-atherosclerotic PAD (e.g. Buerger's disease).
•CLI with major tissue loss (Rutherford Category 6) in either leg.
•Evidence of active infection (e.g., cellulitis, osteomyelitis).
•Subject having undergone surgical revascularization or major amputation less than 1 month prior to screening, or endovascular revascularization or minor amputation less than 2 weeks prior to screening.
•Planned or potential need for major/minor amputation or any revascularization within 1 month of study entry upon investigator's judgment.
•Aorto-iliac stenosis or common femoral artery stenosis ≥70%, or otherwise suspicion of inadequate inflow to the leg.
•Life expectancy of less than 6 months.
•Stroke or acute myocardial infarction/unstable angina within 3 months prior to screening.
•Severe congestive heart failure symptoms (New York Heart Association \[NYHA\] class III-IV).
•Uncontrolled severe hypertension.

Outcomes

Primary Outcomes

Time to major amputation or death (AFS)

Time Frame: Up to 36 months from enrollment

Secondary Outcomes

Time to first occurrence of any of the events (in index leg)-major amputation, revascularization due to worsening of CLI, All-cause mortality.(Up to 36 months from enrollment)
Time to major amputation of the index leg.(Up to 36 months from enrollment)
Change from baseline in ischemic pain as assessed by numerical rating scale (NRS) at 6 months.(6 months from enrollment)
Proportion of subjects with complete healing of all ischemic lesions i.e., ulcers and necroses in the index leg at 12 months.(12 months from enrollment)
Time (days) from randomization to occurrence of death.(Up to 36 months from enrollment)