Data was presented at the American Heart Association meeting in Chicago
on November 17, 2014 regarding the safety and feasibility of Cytori Cell
Therapy using Adipose Derived Regenerative Cells (ADRCs™) administered
through the coronary artery in patients with acute ST segment elevated
myocardial infarction from the ADVANCE clinical trial sponsored by
Cytori Therapeutics, Inc. (NASDAQ: CYTX).
The ADVANCE clinical trial sought to define the safety, feasibility and
efficacy of an intracoronary infusion of ADRCs in patients admitted with
an acute ST-elevation myocardial infarction (STEMI) within 24 hours of
successful primary percutaneous coronary intervention (PCI). In this
randomized, double-blind, placebo-controlled trial (n=23, 2:1
randomization), within 24 hours of successful primary PCI following
STEMI, a small volume liposuction was performed for fat harvest and ADRC
isolation by an automated cell processing system (Celution® System), and
intracoronary infusion within 12 hours of the liposuction.
STEMI patients were routinely treated with dual antiplatelets and
heparin. The decline in hemoglobin following the liposuction procedure
from baseline over the 10 hours following the procedure was
approximately 10%. The liposuction procedure was completed in all but
one patient (stopped due to hypotension, which resolved with termination
of procedure). Intracoronary infusion of the ADRC suspension was
performed successfully in all patients. No impediment of coronary TIMI
flow was observed during or following cell infusion of these
mesenchymal-like cells. No ventricular arrhythmias were observed during
cell infusion. No major adverse cardiac or cerebral events occurred
within 30 days of the procedures.
“Although conclusions from the study are limited by the relatively small
sample size, it appeared that small volume fat harvest for ADRC
preparation and subsequent intracoronary infusion is feasible and can be
performed with an acceptable safety profile in patients with acute STEMI
under dual antiplatelet therapy,” said Dr. Steven Kesten, Chief Medical
Officer. “This finding is consistent with that found in the previously
reported APOLLO trial. Data collection of the one year outcomes has been
completed and will be discussed in a future meeting or communication.”
About Cytori Therapeutics, Inc.
Cytori Therapeutics, Inc. is developing cell therapies based on
autologous ADRCs to treat cardiovascular disease, orthopedic disorders,
complications of immunologic disease, urinary incontinence and thermal
burns combined with radiation injury. Our scientific data suggest ADRCs
improve blood flow, moderate the immune response and keep tissue at risk
of dying alive. As a result, we believe these cells can be applied
across multiple “ischemic” conditions. These therapies are made
available to the physician and patient at the point-of-care by Cytori's
proprietary technologies and products, including the Celution® system
product family. For more information visit www.cytori.com.
Cautionary Statement Regarding Forward-Looking Statements
This communication includes forward-looking statements regarding events,
trends and business prospects, which may affect our future operating
results and financial position. Such statements, including, but not
limited to, those regarding our belief in the safety and feasibility of
the Celution® System cell output in a small volume liposuction to
harvest fat for ADRC preparation and subsequent intracoronary infusion
in patients with acute STEMI under dual antiplatelet therapy are
forward looking statements. Such statements are subject to risks and
uncertainties that could cause our actual results and financial position
to differ materially. Some of these risks include clinical, pre-clinical
and regulatory uncertainties, particularly those inherent in the
developing therapies that are safe and effective for use as human
therapeutics, including risks in the collection and results of clinical
data, final clinical outcomes, dependence on third party performance,
performance and acceptance of our products in the marketplace, and other
risks and uncertainties described under the “Risk Factors” in
Cytori's Securities and Exchange Commission Filings, including in its
most recent annual and quarterly reports. Cytori assumes no
responsibility to update or revise any forward-looking statements
contained in this press release to reflect events, trends or
circumstances after the date of this communication.
Copyright Business Wire 2014