First Heart Failure Patients Successfully Implanted with Angioblast
Systems’ “Off-the-Shelf”
Adult Stem Cells
Multiple US medical centers activly enrolling patients into first
Phase 2 trial of allogeneic stem cells for congestive heart failure
NEW YORK (Business Wire EON/PRWEB ) October 17, 2008 --
Angioblast Systems Inc. today announced successful initial safety
results following commencement of the world’s
first clinical trial to use allogeneic adult stem cells obtained from an
unrelated, universal donor to treat patients with congestive heart
failure.
The multi-center Phase 2 trial is examining the safety and effectiveness
of three different doses of the company’s
proprietary allogeneic, “off-the-shelf,”
universal donor Mesenchymal Precursor Cells (MPCs) injected by catheter
into damaged heart muscle of patients with congestive heart failure.
Safety data from the first seven patients enrolled in the trial by
Angioblast at medical centers in Arizona, California, and Minnesota were
presented today at the Transcatheter Cardiovascular Therapeutics (TCT)
Conference in Washington D.C.
Dr. Nabil Dib, Director of Cardiovascular Research for Chandler Regional
and Mercy Gilbert Medical Centers in Arizona, reported that no adverse
events had occurred in any of the first seven patients following the
catheter procedure.
The placebo-controlled trial of Angioblast’s
Revascor™ MPC cell therapy will randomize up
to 60 patients suffering from congestive heart failure, including those
with non-ischemic cardiomyopathy, to either implantation with allogeneic
adult stem cells or standard of care in a 3:1 ratio.
Angioblast’s Revascor™
adult stem cells are delivered to damaged areas of the heart by a
minimally invasive cardiac catheterization procedure performed under
local anesthesia while the patient is awake. Patients undergoing the
procedure are released from the hospital within 24 hours.
Dr. Dib said: “We hope that the stem cells
will increase the potential for myocardial repair and restoration of
heart function. Angioblast’s Revascor™
cells are a well characterized, pure population of MPCs. These cells,
obtained from a healthy young adult donor, are isolated, expanded and
cultured to produce treatments potentially for thousands of patients.”
According to company founder, Professor Silviu Itescu, “Heart
failure remains a major cause of hospital admissions and patient deaths.
Based on studies to date, our Revascor™ MPCs
have the potential to make a significant impact in patients with heart
failure and to address this major clinical need.
“This Phase 2 clinical trial is an important
step toward our entry into this vital and growing market,”
Professor Itescu said.
About Heart Failure
There are currently five million people in the United States living with
heart failure, and trends indicate that the incidence of heart failure
has not declined in the last 20 years. As the number of people living in
the United States with cardiovascular disease continues to rise at a
rate of 550,000 new cases annually, the health and economic burden of
this disease will greatly impact the population’s
health status. It is estimated that the healthcare cost to care for
heart failure patients is in excess of $29 billion per year.
Heart failure results from the progressive deterioration of the pumping
function of the heart, leading to its inability to pump sufficient blood
to the body’s tissues, organs and limbs. The
majority of heart failure patients have underlying cardiovascular
disorders that are often the precursors of their condition. The most
common of these are atherosclerosis, myocardial infarction,
hypertension, cardiomyopathy and arrhythmia.
About Angioblast Systems, Inc.
Angioblast Systems, Inc. is a private New York City-based biotechnology
company committed to the development of novel treatments for cardiac,
vascular, and eye conditions. Angioblast’s
lead products are based on commercialization of a unique adult stem cell
technology capable of regulating blood vessel growth critical for the
treatment of ischemic heart disease and macular degeneration/diabetic
eye disease. Angioblast’s focus is to
progress through clinical trials and regulatory processes necessary to
commercialise the technology in as short a timeframe as possible.
Angioblast has the worldwide assignment of rights for a series of
patents and technologies that have been developed over more than 10
years and which relate to the identification, extraction, culture
expansion and enablement of adult Mesenchymal Precursor Cells (MPCs).
Revascor™ is a trademark of Angioblast
Systems Inc.
NOTE TO MEDIA: Broadcast quality, high-resolution b-roll footage
and additional images are available upon request.
See the original story at: http://eon.businesswire.com/releases/heart_failure/stem_cells/prweb1462214.htm
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