Clinical Trial: Safety and Efficacy of Allogeneic Cells for the Treatment of Intermittent Claudication(IC)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: 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
Brief 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:
- Double treatment of PLX-PAD low dose
- Double treatment of PLX-PAD high dose
- Double treatment of Placebo
- 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
Detailed Summary:
Sponsor: Pluristem Ltd.
Current Primary Outcome: Log ratio of week 52 maximal walking distance(MWD)to baseline MWD [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Pluristem Ltd.
Dates:
Date Received: September 2, 2012
Date Started: October 2012
Date Completion: April 2018
Last Updated: January 22, 2017
Last Verified: January 2017
