HOUSTON – (Nov. 7, 2013) – Researchers at the Texas Heart Institute (THI) and The University of Texas Health Science Center at Houston (UTHealth) are recruiting patients who suffer from peripheral artery disease (PAD) for a new clinical trial to assess the benefits and risks of using 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.
“It is our hope that state-of-the-art imaging assessments will be sensitive detectors of the injected cells’ effects,” said Lemuel Moyé, M.D., Ph.D., principal investigator at the Cardiovascular Cell Therapy Network (CCTRN) Data Coordinating Center at The University of Texas School of Public Health, a part of UTHealth.
Current available therapies for PAD do not always relieve patients’ leg symptoms, 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.
The PACE trial (Patients with Intermittent Claudication Injected with ALDH Bright Cells), is being conducted under the auspices of CCTRN, a network of cell research centers, including THI, sponsored by the National Heart Lung and Blood Institute (NHLBI).
“Cell therapy has been studied in patients with heart disease and severe PAD,” said Emerson Perin, M.D., Ph.D., 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.”
PACE is a randomized clinical trial that will evaluate leg blood flow and symptoms in two groups of patients - those treated with their own adult stem cells and 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 technology. Preclinical research suggests that ALDH Bright Cells may promote the repair of ischemic tissue damage and restore blood flow through cell recruitment and angiogenesis, which is the formation of new blood vessels. Cytomedix is an industry partner with CCTRN for the PACE trial.
PACE includes an important new scientific component to determine whether state-of-the-art imaging can predict clinical improvement.
The study, which began recruiting in June 2013, is expected to enroll 80 patients.
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