Research

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

Study Looking at Potential Therapy for Leg Pain That Affects Millions


Stemcell_Perin4_cathlab
By Frank Michel | April 17, 2015

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.




Social Posts

profile_image

BCMHouston

@bcmhouston

RT @nwilson_nancy: No one more deserving !! Amazing clinician scientist leader mentor @bcmhouston @IQuEStHouston https://t.co/rhv3aIzE4n

20 mins ago
profile_image

BCMHouston

@bcmhouston

RT @BCMHouston_News: .@bcmhouston gives insight into what type of shower damages your skin. Read about that and other things you might not…

21 mins ago
profile_image

University of Houston

@UHouston

A new breakthrough drug treatment for pancreatic cancer targets two genes simultaneously. https://t.co/i63EFP6SKD

1 hour ago
profile_image

CHI St. Luke's Health

@CHI_StLukes

What are #TraumaticBrainInjuries? Do #concussions count? Craig DiTommaso, MD, Medical Director of Rehabilitation Services at Baylor St. Luke's, gives us the scoop. https://t.co/efvosShzma

1 hour ago
profile_image

University of Houston

@UHouston

RT @UHOnlineCoogs: UH has several certificate programs that can upgrade your skills and qualifications in professional fields with credit b…

1 hour ago
profile_image

Veterans Affairs

@DeptVetAffairs

Army Veteran survives multiple medical challenges and is now inspiring other Veterans at annual VA event https://t.co/gZfNO6a3CL via #VAntagePoint

1 hour ago
profile_image

TexasHeartInstitute

@Texas_Heart

James T. Willerson Seminar Thursday at 4 PM – Jun Wang, MD, PhD, @Texas_Heart “The Sumoylation Pathway: A Global Regulator of Cardiac Function” https://t.co/v9uBsIPFhJ https://t.co/NMfxGo5Ini

1 hour ago
profile_image

University of Houston

@UHouston

RT @uhrecreation: Want a chance to win a free pair of Bose wireless earbuds, a JBL splash proof speaker, or a $25 giftcard of your choice?…

2 hours ago
profile_image

BCMHouston

@bcmhouston

RT @BCMCancer: Thank you Harley's Angels for your generous donation to help fund cancer research! Over the last 15 years, they have given n…

2 hours ago
profile_image

Rice University

@RiceUniversity

RT @HoustonPubMedia: With the goal of making #college more #affordable for more families, @RiceUniversity will give full tuition #scholarsh…

2 hours ago
profile_image

UTHealth

@UTHealth

In recognition of #WorldAlzheimersDay, Dr. Ines Moreno Gonzalez of @McGovernMed discusses the latest research on the disease: https://t.co/ALPClgiAM3

2 hours ago
profile_image

UTHealth

@UTHealth

@panina_89 Awesome!

2 hours ago
profile_image

Veterans Affairs

@DeptVetAffairs

Community Based Outpatient Clinic in Myrtle Beach has reopened today https://t.co/o3KpG5L0x1…veterans-affairs/

2 hours ago
profile_image

Veterans Affairs

@DeptVetAffairs

$7.2 Million Grant to Create SW Louisiana Veterans’ Cemetery https://t.co/y83WMFyIWh via @usnews

2 hours ago
profile_image

TAMU Health Sciences

@TAMHSC

The @TAMUmedicine presents: SHIFT 2018 – Texas Health Challenges Case Competition. Students from 7 Texas medical schools gain experience working in collaborative teams to design innovative solutions to address major health care issues affecting #Texas. https://t.co/SpMamSelHi https://t.co/oYAXgdI3sr

3 hours ago