PACE Study — A randomized, double-blind, multicenter, placebo-controlled, parallel-group Phase 3 study 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 who are unsuitable for revascularization

HS 2018-4754
Peripheral artery disease, Wound ischemia, Vascular disease, Limb ischemia
Isabella Kuo, MD
UCI Health Vascular Surgery at UCI Medical Center and the UCI Institute for Clinical and Translational Sciences at UC Irvine

The purpose of this research study is to evaluate the efficacy (how well it works), tolerability and safety of a cellular therapy in patients with critical limb ischemia (CLI) with minor tissue loss who are not considered good candidates for surgery or other procedures designed to increase blood flow.

Please note this may not be a complete list of eligibility criteria. We have included a few examples of study criteria to help you better understand how your eligibility in the study will be determined; the study team will go through the study eligibility criteria with you to verify if you qualify for participation in this study.

Inclusion requirements

You can participate in this study if you:

  • Are between ages 45 and 99
  • Have peripheral artery disease (PAD) with ischemic wounds that meet the study criteria
  • Can provide written informed consent

Exclusion requirements

You cannot participate in this study if you:

  • Are pregnant
  • Have other serious illnesses involving your heart, lungs, kidneys or liver
  • Have had surgical treatment to restore blood flow or major amputation within the past month

The study involves a screening period of approximately five (5) weeks consisting of two (2) visits. If you are eligible to enter the study, you will receive one of the above-mentioned treatments, PLX-PAD, or a placebo. You will be followed for a period of time ranging between 12 months (1 year) to 36 months (3 years), depending on the date you entered into the study and study end date.

If you are in the group that receives PLX-PAD and it proves to treat your condition and improves blood flow to the ischemic limb, you may benefit from participating in the study, but this cannot be guaranteed.

This study will help researchers learn more about how to treat critical limb ischemia, and it is hoped that this information will help in the treatment of future patients with conditions like yours.

You will be paid $50 in the form of gift card at specified time points over the course of the study. Any time you come to see your doctor for a study-related visit, you will be given $50 to help with your travel and meal expenses. If you decide to withdraw from the study or are withdrawn by the research team, you will receive compensation for the visits and/or procedures you have completed.

Stem cell therapy
Jinah Chung, UCI Alpha Stem Cell Clinic