LOUISVILLE, Ky. – A network of cell therapy research centers established by a National Institutes of Health (NIH) grant at the University of Louisville is now enrolling patients in its first clinical trial – a Phase II study of a novel adult stem cell treatment for peripheral arterial disease (PAD). The condition occurs when plaque builds up in the arteries and ultimately blocks blood flow to the legs.
In 2012, Dr. Roberto Bolli was awarded $3.4 million over seven years from the NIH’s National Heart, Lung and Blood Institute to participate in the Cardiovascular Cell Therapy Research Network (CCTRN), a consortium of seven adult stem cell centers in the United States with expertise in conducting clinical trials of novel treatments for cardiovascular diseases.
With UofL, CCTRN members are Stanford University, Texas Heart Institute, University of Florida, University of Miami, Minneapolis Heart Institute Foundation, and Indiana University.
At UofL, the study will be led by Bolli, director of the Institute of Molecular Cardiology, chief of the Division of Cardiovascular Medicine and the Jewish Hospital Heart & Lung Institute Distinguished Chair in Cardiology. The clinical trial, “Patients with Intermittent Claudication Injected with ALDH Bright Cells,” is known as PACE. The goal is for the CCTRN sites to collectively enroll 80 patients in one year.
PAD affects between 8 and 10 million Americans, usually in the arteries of the legs. The primary leg symptom is called “intermittent claudication,” which occurs in 1 to 3 million Americans and is characterized by pain, numbness, aching, cramping or heaviness in the leg muscles.
“Adult stem cell therapy has been studied in patients with heart disease and severe PAD but it has not been adequately evaluated in individuals with intermittent claudication,” Bolli said. “The PACE trial will be among the first studies to do so.”
PACE is a randomized, placebo-controlled study in which patients will be followed for one year. The treatment group will receive what are known as aldehyde dehydrogenase bright cells, which are stem cells taken from the patient’s bone marrow and then processed through a technology owned by the company Cytomedix Inc. (OTC: CMXI), an industry partner in the trial.
Trial participants must be age 40 or older and have PAD with claudication. For more information, call 502-587-4106 or 502-407-3259 or visit the National Institutes of Health clinical trials website at ClinicalTrials.gov, using the trial identifier number, NCT01774097.