First Patients Treated in Cytori's Stem & Regenerative Cell Heart
Attack Study
SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics (NASDAQ:CYTX)
enrolled the first two patients in a clinical trial using adipose-
derived stem and regenerative cells in the treatment of heart attack.
In this trial, patients' cells are made available using Cytori's
Celution™ System, a real-time cell processing device. One patient has
been enrolled in each trial center, Hospital Universitario Gregorio
Marañón in Madrid, Spain, and Thoraxcenter, Erasmus Medical Center in
Rotterdam, The Netherlands.
Fat, known medically as adipose tissue, is one of the body's richest
known sources of regenerative cells. Adipose-derived regenerative
cells include adult stem cells in addition to other important cell
types that have been shown to increase blood flow in and around
damaged and oxygen deprived tissues. As a result, these cells hold
exciting potential to revolutionize the treatment of heart disease,
which affects millions of patients worldwide each year.
"Time is of the essence in the treatment of patients with heart
attacks," said Prof. PW. Serruys, M.D., Ph.D., principal investigator
for the trial and Head of the Department of Interventional Cardiology
at the Thoraxcenter, Erasmus Medical Center. "The Celution™ System
makes adipose-derived regenerative cells available in real-time and
enables early treatment. For this reason, adipose-derived
regenerative cells processed by the Celution™ System could play a
critical role in limiting or reversing heart damage caused by a heart
attack."
"A major challenge in cardiovascular cell therapy is having a
meaningful number of stem and regenerative cells," said Francisco J.
Fernández-Avilé
Universitario Gregorio Marañón and an investigator for this APOLLO
trial. "To date, we have treated a number of patients with chronic
ischemia in Cytori's PRECISE trial, and we are pleased that the
Celution™ device has enabled us to administer a meaningful dose of
their own cells in real-time."
The APOLLO trial is a 48-patient, randomized, placebo-controlled,
dose escalation, safety and feasibility multi-center study. A dose of
adipose-derived regenerative cells, or a placebo, will be delivered
through an intracoronary catheter within 36 hours following the onset
of a heart attack. The trial will involve four groups of 12 patients
each. In each group, nine patients will receive cells and three will
receive the placebo control. Cytori is the sole sponsor of the APOLLO
clinical trial.
"The Celution™ System is unique in its ability to potentially address
acute and chronic heart conditions using a patient's own cells," said
Alex Milstein, M.D., Vice President, Clinical Development, Cytori
Therapeutics. "Cytori's comprehensive clinical development program
for the Celution system addresses chronic ischemic heart disease as
well as in acute heart attack. The initiation of the APOLLO trial is
an important milestone that has a potential of bringing innovative
treatment options for patients with acute heart attack."
Cytori Therapeutics
Cytori Therapeutics' (NASDAQ:CYTX) goal is to be the global leader in
regenerative medicine. The company is dedicated to providing patients
with new options for reconstructive surgery, developing treatments
for cardiovascular disease, and banking patients' adult stem and
regenerative cells. To reach its goal, Cytori is developing its
innovative Celution™ System to separate and concentrate a patient's
own adult stem and regenerative cells from adipose (fat) tissue for
these cells to be delivered back to the patient during the same
surgical procedure. In 2008, the Celution™ System is being introduced
in Europe into the reconstructive surgery market and launched in
Japan for cryopreserving a patient's own stem and regenerative cells.
Clinical trials are ongoing or planned in cardiovascular disease,
spinal disc degeneration, gastrointestinal disorders, and other unmet
medical needs. www.cytoritx.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding
events, trends and prospects of our business, which may affect our
future operating results and financial position. Such statements are
subject to risks and uncertainties that could cause our actual
results and financial position to differ materially. Some of these
risks and uncertainties include our history of operating losses, the
need for further financing, regulatory uncertainties, dependence on
performance of third parties, and other risks and uncertainties
described (under the heading "Risk Factors") in Cytori Therapeutics'
Form 10-K annual report for the year ended December 31, 2006. We
assume no responsibility to update or revise any forward-looking
statements to reflect events, trends or circumstances after the date
they are made.
Contacts
Cytori Therapeutics
Tom Baker, 858-875-5258
tbaker@cytoritx.
http://www.business
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