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.
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.
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.
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."
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
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.
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.
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.
also includes an important new scientific component to determine whether state-of-the-art
imaging can predict clinical improvement.
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.
To learn more about PAD, visit the THI Heart Information Center topic on peripheral vascular disease. For media inquiries please contact:
Director of Public Affairs
Texas Heart Institute
Frank Michel ♦ 832-355-9510 ♦ firstname.lastname@example.org
For THI media profile, see Public Affairs.