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Format: 04/18/2014
Format: 04/18/2014

News

AGH Study Explores Potential of Novel Stem Cell Therapy For Heart Attack

Thursday, November 19th, 2009

Researchers at the Allegheny General Hospital (AGH) Gerald McGinnis Cardiovascular Institute have embarked upon a landmark Phase II clinical trial exploring the safety and efficacy of a novel, adult stem cell therapy for the treatment of acute myocardial infarction (acute MI) – or heart attack. 

Sponsored by Osiris Therapeutics, Inc., one of the world’s pioneers in stem cell therapy, the new study is evaluating the use of Prochymal®, a formulation of mesenchymal stem cells obtained from the bone marrow of healthy adult donors that is specially designed for intravenous infusion.

Prochymal® is believed to provide therapeutic benefit to heart attack patients by controlling inflammation, promoting tissue regeneration and preventing scar formation, addressing the three primary complications associated with permanent heart muscle damage and poor outcomes following acute MI.

AGH is the only medical center in western Pennsylvania and just the third in the Commonwealth to offer patients access to the Osiris study. The hospital is one of 38 leading U.S. medical centers involved in the trial, which requires the specialized services of both advanced interventional cardiology and cardiovascular magnetic resonance imaging (MRI) capabilities. AGH has the only dedicated Cardiovascular MRI program in the state.

Others participating in the Osiris study include Johns Hopkins Hospital, the University of California-San Diego, Minneapolis Heart Institute, The Ohio State University, William Beaumont Hospital and Drexel University College of Medicine.

A 53 year-old Scott Township woman became the first patient enrolled in the study at AGH on November 6. Approximately 220 patients will be enrolled in the trial nationwide.

According to Robert Biederman, M.D., director of AGH’s Cardiovascular MRI Center and the hospital’s principal investigator for the study, the Phase I trial evaluating Prochymal® in heart attack patients demonstrated its potential as a new approach to treating one of the leading killers of men and women.

The American Heart Association estimates that more than 900,000 people in the U.S. suffer heart attacks each year, and 600,000 of those are first time heart attacks.

“Though preliminary, results of the Phase I trial with this therapy were groundbreaking, suggesting that a relatively easily administered IV drug may significantly improve recovery from acute MI and prevent its long-term adverse effects. If we can duplicate those results in our larger, subsequent investigation it would represent a major milestone in the treatment of this formidable disease” Dr. Biederman said.

In a February 2009 press release, Osiris Therapeutics reported that patients treated with Prochymal® in the Phase I study had lower rates of adverse events and substantially improved outcomes. This suggests that Prochymal® is able to prevent scar formation and pathological remodeling of the heart muscle, as evident in both electrical and mechanical cardiac performance measures. The Phase I data is scheduled to be published in the Journal of the American College of Cardiology in December of this year.

Patients receiving Prochymal® experienced fewer post MI arrhythmias compared to those receiving placebo (11.8% vs 47.4%). Ventricular arrhythmias are associated with tissue damage and scar formation in the heart resulting from MI and often signal a poorer prognosis.

Two year data collected from cardiac MRI in the Phase I study also showed statistically significant improvement in left ventricular ejection fraction (LVEF) over baseline associated with Prochymal® compared to placebo. LVEF reflects the fraction of blood pumped out of a ventricle with each heart beat. A common measurement of overall heart function, LVEF typically declines after heart attack and patients with severely compromised LVEF progress to heart failure.

“If proven, this novel therapy could reduce the relatively unchanged ‘in-hospital’ mortality that we have experienced over the last 8-10 years for acute heart attacks, where 5-6% of such patients still die and countless more have dire complications that lead to chronic cardiovascular distress,” said Jerome Granato, M.D., director of AGH’s Coronary Care Unit and a co-investigator in the Osiris study.

The Phase II double blind, placebo-controlled trial being conducted at AGH will evaluate the effectiveness of Prochymal® in conjunction with standard therapies among patients experiencing a first heart attack. The trial will focus on patients age 21 to 85 years who have suffered more severe heart attacks than those investigated in the first study, defined as LVEF between 30% and 45% at baseline.

Prochymal® is delivered to patients via a one-time IV-infusion that takes approximately forty minutes. The treatment can be administered up to seven days after a heart attack has occurred, Dr. Biederman said.

The study is a collaborative effort that also involves AGH cardiovascular researcher Michael Passineau, Ph.D., who prepares the stem cells for delivery, and W. Joseph Carothers, RN who is a study coordinator and oversees infusion of the drug. Dr. Granato performed the diagnostic catheterization on the first patient enrolled.

Study participants will be followed for two years and progress will be assessed using cardiac MRI and ultrasound, in addition to the standard battery of cardiac measures, including electrocardiogram and heart function monitoring.

Those interested in the Osiris study at AGH, including those who have had a recent heart attack in the last 7 days, can call either Dr. Biederman (412 359-8705) or Mr. Carothers (412-359-4156).

 
 

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