News | November 06, 2007

Stem Cells Infused with Catheter Found Safe, May Boost Heart Function

November 7, 2007 – Injecting patients’ own stem cells – ones that exist in skeletal muscle – directly into the heart with a three-dimensional guided catheter is feasible, safe and might be superior to optimal medical therapy (OMT), researchers reported in a late-breaking special session on stem cell research at the American Heart Association Scientific Sessions 2007.

Researchers directed the Catheter-Based Delivery of Autologous Skeletal Myoblasts for Ischemic Cardiomyopathy: Feasibility, Safety and Improvement in Cardiac Performance (CAuSMIC) trial to evaluate the effect of adding autologous skeletal myoblasts (ASM) transplantation to Optimal Medical Treatment (OMT), compared to OMT alone.

In the randomized, controlled open-label study, the research team gathered cells from patients’ thigh muscles, removing a piece of tissue about the size of a quarter and separating the stem cells. These cells, called myoblasts, were then grown to increase their number and injected into the heart via an investigational catheter using a three-dimensional voltage mapping system “like a small Global Positioning Satellite system,” said Nabil Dib, M.D., director of clinical cardiovascular cell therapy and associate professor of medicine at the University of California in San Diego.

This Phase 1 trial focused on feasibility and safety, but researchers also examined the preliminary efficacy of the procedure. Researchers enrolled 23 heart failure patients whose hearts were pumping inadequately (ejection fraction scores of 40 percent or less). The patients had previously suffered heart attacks and were receiving OMT at the beginning of the trial. Twelve received ASM and OMT and 11 continued receiving OMT alone.

At one year, researchers reported all ASM procedures were successful without injection-related complications, and with no deaths in either group. One person in each group experienced abnormal and rapid heartbeat but both were successfully treated with implantable cardioverter defibrillators. At 12 months follow-up, there were no significant differences in control versus treated patients concerning the occurrence of arrhythmias. ASM-treated patients on average had improved pumping function, reported better quality of life on a questionnaire, and the size of their overworked left ventricles had decreased. These patients showed favorable outcomes at all myoblast doses, including the highest dose of 600 million cells. On average, OMT patients got worse on each measure.

“These data demonstrate the safety and suggestively positive outcomes of ASM transplantation and warrant initiation of larger Phase 2, double-blind, placebo controlled clinical trials to demonstrate the efficacy of myoblast transplantation in heart failure patients,” Dib said.

Support for this study was provided by Mytogen, Inc.

Statements and conclusions of study authors that are presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The American Heart Association makes no representation or warranty as to their accuracy or reliability.

For more information: www.americanheart.org

Related Content

Secant Introduces First Synthetic Regenerative Cardiovascular Graft for CABG
News | Stem Cell Therapies | January 17, 2018
Secant Group, in partnership with its sister company SanaVita Medical, announced new technology to advance...
News | Stem Cell Therapies | October 24, 2017
October 24, 2017 — Roche and Ncardia have reached a broad licensing agreement whereby Roche and its affiliate compani
BioCardia Announces 12-Month Results from TRIDENT Trial of Stem Cell Delivery System
News | Stem Cell Therapies | September 26, 2017
BioCardia Inc. recently announced 12-month results from the Phase II TRIDENT clinical trial, conducted by the...
New Jersey Researcher Exploring New Stem Cell Therapies for Heart Attacks
News | Stem Cell Therapies | August 04, 2017
In petri dishes in her campus laboratory at New Jersey Institute of Technology, Alice Lee is developing colonies of...

An example of porcine cartdiac stem cells. Photo from the University of Miami Miller School of Medicine.

 

News | Stem Cell Therapies | June 12, 2017
June 12, 2017 — Heart muscle is one of the least renewable tissues in the body, which is one of the reasons that hear
Stem Cell Therapy Holds Promise for Treating Most Severe Cases of Angina
News | Stem Cell Therapies | May 12, 2017
An analysis of data from the entire development program consisting of three trials assessing the feasibility of using a...
3-D Printed Patch Can Help Mend a ‘Broken’ Heart

This photo shows the 3D-bioprinted cell patch in comparison to a mouse heart. When the patch was placed on a live mouse following a simulated heart attack, the researchers saw significant increase in functional capacity after just four weeks. Image courtesy of Patrick O’Leary, University of Minnesota.

News | Stem Cell Therapies | April 18, 2017
April 18, 2017 — A team of biomedical engineering researchers, led by the University of Minnesota, has created a revo
Texas Heart Institute, ischemic heart failure, adult stem cell therapy, CONCERT-HF clinical trial
News | Stem Cell Therapies | February 03, 2017
Physicians and researchers at Texas Heart Institute are recruiting patients who suffer from heart failure to...
News | Stem Cell Therapies | January 09, 2017
BioCardia Inc. announced in December the issuance of United States Patent No. 9,517,199 relating to a method of...
Overlay Init