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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

NCT03006770 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2024-08-30

No results posted yet for this study

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.

Conditions

  • Critical Limb Ischemia (CLI)

Interventions

BIOLOGICAL

PLX-PAD

Local intramuscular (IM) injections of PLX-PAD in the index leg.

BIOLOGICAL

Placebo

Local intramuscular (IM) injections of Placebo in the index leg.

Sponsors & Collaborators

  • Pluristem Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-22
Primary Completion
2021-03-03
Completion
2022-04-20
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • Germany
  • Hungary
  • Israel
  • North Macedonia
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03006770 on ClinicalTrials.gov