Doctors and researchers at the Texas Heart Institute (THI) are halfway to their goal of recruiting 80 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. Current treatments are associated with risk, may not provide longstanding symptom relief, and/or may not be 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.”
Researchers are excited to announce that the study is halfway toward its goal of recruiting 80 patients. The Stem Cell Center continues to work and is actively seeking referrals from the surrounding healthcare community. The goal is to complete enrollment in this trial by the end of 2015.
“It is important that patients who think they might be eligible and physicians with patients who may benefit from the study contact us soon” said Dr. Perin.
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).
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 pluripotent (develop into many cell types) stem cells isolated from the patients’ own bone marrow (autologous) through a proprietary Cytomedix technology. Preclinical research suggests that ALDH Bright Cells may promote the repair of tissue damage caused by inadequate blood supply (ischemia) 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. “It is our hope that state-of-the-art imaging assessments will be sensitive detectors of the injected cells’ effects,” added Dr. Lem Moyé, principal investigator at the CCTRN Data Coordinating Center at the University of Texas School of Public Health in Houston.
Don't miss tonight's @RiceScientia event with Pres. Leebron. "What’s a Fact Anyway? Insights from a Journalist, a S… https://t.co/6pEQykzWj6
Lahontan Valley VA Clinic celebrates grand opening https://t.co/CPt1MUQrAY via @KOLO8
The @ReelAbilityHou Film Festival, Feb. 12-22, is a FREE city wide film and arts festival that promotes inclusion a… https://t.co/BJK5C87Fwo
U.S. Department of Veterans AffairsVeteransAffairs
Aimed at supporting Veterans deploying into the world of entrepreneurship, Bunker Labs PHL’s Launch Lab provides 16 weeks of programming, mentoring and networki...
Palm Beach Daily Newsshinysheet
MD Anderson doctors discuss new treatments at The Colony in Palm Beach
TAMU Health Sciences@TAMHSC
Interprofessional education can improve health care and provide care to under-served populations… https://t.co/AryFDKCJDD
University of Houston@UHouston
Solving the world's water crisis....from SPACE. 🛰 #UHPowerhouse https://t.co/1c1euaXKOc
Don't let #stress throw you for a loop! See how you can lead a more balanced life. https://t.co/T3zHK0UdTg
Baylor College of MedicineBaylorCollegeOfMedicine
Did you know that 1 in 26 people will develop epilepsy in his or her lifetime? Learn more about epilepsy and some treatment options available in our blog.
See #RiceUniversity through the eyes of our roving campus photographers 📸— https://t.co/frRec71yxt https://t.co/Wc0VKbhEbo
RT @HeartNews: Have you read about our updated blood pressure guidelines? Find out how this impacts you. https://t.co/pFc80tvHq4 https://t.…
RT @IlseMonette: Did you know that January is #CervicalHealthAwarenessMonth? @UTHealth expert is here to talk about what can be done to pre…
RT @MDA_UTHGrad: Don't forget: GSA town hall meeting: Tomorrow, Jan. 24, 1p.m., GSBS Large Classroom, S3.8371. Learn about what's happening…
Vietnam Veteran shares story of struggles and success https://t.co/22nTkABuit via @foxillinois
Belle UsmanBelle Usman
What do I do when I can’t get sleep at night? I’m an Endometrial CA IVB patient and just had a surgery for over a month and feeling weak and tired all the time ...