NCT01679990

Safety and Efficacy of Allogeneic Cells for the Treatment of Intermittent Claudication(IC)

A Phase II, Randomized, Double-Blind, Multicenter, Multinational, Placebo-Controlled, Parallel- Groups Study to Evaluate the Safety and Efficacy of Intramuscular Injections of Allogeneic PLX-PAD Cells for the Treatment of Subjects With Intermittent Claudication (IC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Pluristem Ltd. · Industry
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to establish the safety profile of Intramuscular PLX-PAD injections and to evaluate the clinical efficacy of it in IC subjects comprising of 4 treatment groups: 1. Double treatment of PLX-PAD low dose 2. Double treatment of PLX-PAD high dose 3. Double treatment of Placebo 4. Single treatment of PLX-PAD high dose and additional treatment of Placebo. Subjects will receive the assigned treatment twice to the affected leg, within 12-weeks interval between each treatment. The study will be comprised of 5 stages: Screening period of up to 4 weeks,first treatment of PLX-PAD or placebo followed by additional injection after 12 weeks and with follow-up of 12 months post second injection

Conditions

• Intermittent Claudication
• Peripheral Artery Disease

Interventions

Type	Name	Description
BIOLOGICAL	PLX-PAD Low dose
BIOLOGICAL	PLX-PAD high doses
BIOLOGICAL	Double Placebo
BIOLOGICAL	high dose +Placebo

Timeline

• Start date: 2012-11-05
• Primary completion: 2018-03-29
• Completion: 2019-02-09
• First posted: 2012-09-06
• Last updated: 2019-02-12

Locations

34 sites across 4 countries: United States, Germany, Israel, South Korea