Texas Heart Institute Recruiting Patients with
Peripheral Artery Disease for Adult Stem Cell Trial

Study Looks at Potential Therapy for Leg Pain That Affects Millions  

Houston, Texas (October 15, 2013)  – Doctors and researchers at the Texas Heart Institute (THI) are recruiting patients who suffer from peripheral artery disease (PAD) for a new clinical trial to assess the benefits and risks in the use of adult stem cells from patients' own bone marrow to treat leg pain commonly associated with the disease. 

PAD affects between 8 million and 10 million Americans. The primary leg symptom is called "intermittent claudication," which can manifest as aching, cramps, numbness or feeling of fatigue in the leg muscles. These symptoms occur in approximately 1 million to 3 million sufferers of the disease.   

Many with PAD may not be able to enjoy a relief of these leg symptoms with any of the currently available therapies, which range from exercise to medications to endovascular and open surgical options. Many current treatments are associated with risk, may not provide longstanding symptom relief, and/or are not cost-effective. 

"Cell therapy has been studied in patients with heart disease and severe PAD," said Dr. Emerson Perin, director of THI's Stem Cell Center, "But, it has not been adequately evaluated in individuals with intermittent claudication.  We are hoping to change that." 

The PACE trial (Patients with Intermittent Claudication Injected with ALDH Bright Cells) is being conducted under the auspices  of the  Cardiovascular Cell Therapy Network (CCTRN), a network of cell research centers, including THI, sponsored by the National Heart Lung and Blood Institute (NHLBI).   

"It is our hope that state of the art imaging assessments will be sensitive detectors of the injected cells' effects," added Dr. Lemuel Moyé, principal investigator at the CCTRN Data Coordinating Center at the University of Texas School of Public Health in Houston. 

PACE is a randomized clinical trial that will evaluate leg blood flow and symptoms in two groups of patients: a) those treated with their own adult stem cells, and b) those treated with placebo.  All patients will be followed for one year.  

The treatment group will receive ALDH Bright Cells (ALD-301), which are an autologous pluripotent stem cell isolated from the patients' own bone marrow through a proprietary Cytomedix techonology. Preclinical research suggests that ALDH Bright Cells may promote the repair of ischemic tissue damage and restore blood flow through cell recruitment and angiogenesis (the formation of new blood vessels). Cytomedix is an industry partner with CCTRN for the PACE trial.  

PACE also includes an important new scientific component to determine whether state-of-the-art imaging can predict clinical improvement. 

The study began recruiting in June 2013 and is expected to enroll 80 patients in one year. More information on the PACE trial is available at  www.texasheart.org/stemcell.
 

Director of Public Affairs
Texas Heart Institute
Frank Michel  ♦  832-355-9510  ♦  fmichel@texasheart.org 

For THI media profile, see Public Affairs.