First preclinical report of autologous stem cells harvested and administered the day of heart attack
San Diego, CA, October 17, 2005 - Cytori Therapeutics, Inc. (Frankfurt: XMP), today presented results demonstrating that adipose stem and regenerative cells improved cardiac function following a severe heart attack in a porcine study. This is the first preclinical study in which the injected cells were autologous, meaning they came from the animals’ own tissue, were not cultured, so that they did not undergo multiple cell divisions to achieve a target dose of cells, and were harvested and administered on the day of the heart attack. The results of the study, conducted in collaboration with Tulane University, were presented at the Cardiovascular Research Foundation’s 17th Annual Transcatheter Cardiovascular Therapeutics Scientific Symposium in Washington, D.C. (abstract no. 158).
In this randomized study, 17 animals received either injections of their own adipose stem and regenerative cells (treated) or a saline injection (control) via catheter into the artery at the site of the heart attack. After eight weeks, there was a statistically significant reduction in the perfusion defect, which is the area of the heart deprived of oxygen as a result of the infarct. A corresponding benefit was observed by the improvement in ejection fraction, a common measure of the heart’s pumping efficiency.
“Our study was unique in that the animals received an injection of autologous cells that were not cultured and administered immediately following a heart attack,” said Marc H. Hedrick, M.D., President for Cytori Therapeutics. “Additionally, it shows that a sufficient number of cells could be accessed from adipose tissue in real-time to achieve a therapeutic effect, which closely approximates a clinical setting where timely delivery may be critical. These data confirm our previous results and will serve as an important component of our forthcoming application to initiate European clinical studies next year.”
Perfusion Defect (%)
|
|
Baseline Post- Heart Attack (T=0) |
8 weeks* |
% Improvement |
|
|
Adipose Stem Cells |
41±8 |
35±9 |
+ 6 |
|
|
Control |
39±6 |
44±5 |
- 5 |
Ejection Fraction (%)
|
|
Baseline Post- Heart Attack (T=0) |
8 weeks |
% Improvement |
|
Adipose Stem Cells |
32±13 |
42±11 |
+ 10 |
|
Control |
35±10 |
31±10 |
- 4 |
Adipose tissue, also known as fat, is an abundant source of stem cells and other regenerative cells that can contribute to the repair and healing of damaged tissue. These cells have been shown to reduce the extent of a heart attack and promote restoration of heart function by a variety of mechanisms, including promotion of blood vessel growth, and differentiate into cardiac muscle tissue.
About Cytori Therapeutics
Cytori Therapeutics (Frankfurt: XMP) is discovering and developing proprietary cell-based therapeutics utilizing adult stem cells derived from adipose tissue, also known as fat. The Company’s preclinical investigational therapies target cardiovascular disease, spine and orthopedic conditions, gastrointestinal disorders and new approaches for aesthetic and reconstructive surgery. To facilitate processing and delivery of adipose stem cells, Cytori is developing its proprietary Celution™ system to isolate and concentrate a patient’s own stem cells in about an hour. This system will dramatically improve the speed in which personalized cell-based therapies can be delivered to patients.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events and trends which may affect Cytori Therapeutics’ future operating results, cell therapy product development, and financial position. Such statements are subject to risks and uncertainties that could cause the Company’s actual results, product development timelines, and financial position to differ materially. Some of these risks and uncertainties are described (under the heading “Risk Factors”) in Cytori Therapeutics’ 2004 Form 10-K annual report for the year ended December 31, 2004 and subsequent SEC filings, which are available through the Company’s web site. Cytori Therapeutics assumes no responsibility to update any revision of forward-looking statements to reflect events, trends or circumstances after the date they are made.