Injecting Patient's Own Stem Cells Treat?s Severe Coronary Artery Disease

Encouraging 12-month results from a
Phase I trial investigating the injection of adult, autologous CD34+ stem
cells into the hearts of patients with severe coronary artery disease will
be presented for the first time at the Cardiovascular Research Foundation's
(CRF) eighteenth annual Transcatheter Cardiovascular Therapeutics (TCT)
scientific symposium in Washington, D.C. The data provide evidence that
this therapy is well tolerated at this stage and that larger, Phase II
clinical trials can continue in humans.



Douglas Losordo, MD, chief of cardiovascular research at Caritas St.
Elizabeth's Medical Center, a major academic medical center affiliated with
Tufts University School of Medicine, is the principal investigator of the
Phase I trial investigating this therapy that involves injecting patients
with severe coronary artery disease with a protein that helps to release
stem cells from the patient's own bone marrow into the blood stream. These
autologous stem cells are gathered, selected and then injected into areas
of the heart that have been damaged due to an insufficient supply of
oxygen-rich blood.



Data from this randomized, multi-center, placebo-controlled,
double-blind trial indicate that the therapy appears to be well-tolerated
as no serious adverse events directly related to the stem cell therapy were
observed.



Twenty-four patients were enrolled at three centers in the United
States from December 2003 through March 2005. There were five females and
19 males with a mean age of 63. Through the duration of the study, there
were no deaths or heart attacks. Fifteen of the 18 total Phase I study
subjects who received the cells reported feeling better with reductions in
chest pain and/or improved exercise capacity. Though not sufficiently
powered to prove efficacy, these results did lead the way to the initiation
of a randomized, multi-center, placebo-controlled, double-blind Phase II
trial, sponsored by the Cellular Therapies business unit of Baxter
Healthcare Corporation, in a larger (150 patient) study population.



The American Heart Association estimates that every year, between
125,000 and 250,000 individuals with coronary artery disease develop
chronic myocardial ischemia (CMI), one of the most severe forms of coronary
artery disease, which can cause unstable angina, heart attacks and
progressive heart failure when adequate blood flow is not restored. While
cardiologists can restore blood flow in some cases, the heart muscle can be
irreversibly damaged, leading to significant disability, progressive heart
failure and often death.



"Heart disease is the number one killer of adults in this country, and
yet, as clinicians, we are unable to adequately treat many patients with
the severest forms of the disease," said Losordo. "The Phase I results
demonstrated that patients suffering from severe coronary artery disease
who receive injections of their own stem cells can tolerate this treatment.
By moving forward with the Phase II trial, we have reached a milestone in
exploring further a much-needed therapy for this patient population."



Losordo's presentation will take place at TCT 2006 on Monday, October
23, 2006 at 11:00 am EDT. The Featured Lecture session will be held in Room
147AB of the Washington Convention Center and is titled "First Report of
the 1-Year Results of a Double-Blind, Placebo-Controlled, Randomized Trial
of CD34+ Cells for Intractable Myocardial Ischemia."



Caritas St. Elizabeth's Medical Center is a major academic medical
center affiliated with Tufts University School of Medicine. Areas of
medical excellence include cardiology and cardiovascular research,
neurosciences, women's health, high-risk obstetrics, bone and joint health,
hematology/oncology, pulmonary medicine and gastroenterology. Caritas St.
Elizabeth's is a member of Caritas Christi Health Care, the second largest
health care system in New England.


Caritas St. Elizabeth's Medical Center

Caritas St. Elizabeth's Medical Center

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