First Patients Treated In Cytori's Stem & Regenerative Cell Heart Attack Study

Main Category: Cardiovascular / Cardiology
Also Included In: Stem Cell Research
Article Date: 01 Feb 2008 - 3:00 PDT

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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-Avilés, Chief of Department of Cardiology at Hospital 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.

http://www.cytoritx.com

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.

Cytori Therapeutics