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MacroPore Biosurgery Preclinical Safety Study Shows Adipose Tissue-Derived Regenerative Cells Improve Heart Function After Heart Attack.


SAN DIEGO -- MacroPore Biosurgery, Inc. (Frankfurt:XMP (X/Open Management Protocol) A high-level network management protocol governed by X/Open. Network management software written to the XMP interface is shielded from the details of the underlying SNMP or CMIP protocols. ) today announced that adipose adipose /ad·i·pose/ (ad´i-pos)
1. fatty.

2. the fat present in the cells of adipose tissue.


ad·i·pose
adj.
Of, relating to, or composed of animal fat; fatty.
 tissue-derived regenerative cells improved heart function following myocardial infarction myocardial infarction: see under infarction.  (heart attack) in a large-animal preclinical safety study. This study, performed in swine, confirms previous preclinical work by MacroPore Biosurgery and others suggesting that the Company's proprietary, patented technology is safe and may be clinically useful in treating heart disease. The goal of the study was to determine the safety of adipose tissue-derived regenerative cells delivered into coronary circulation without cell culture. The results were presented in a poster at the Cardiovascular Research Foundation's (CRF CRF
abbr.
chronic renal failure


CRF Chronic renal failure
) Sixteenth Annual Transcatheter Cardiovascular Therapeutics Scientific Symposium (TCT TCT The Capital Times (Madison, WI newspaper)
TCT Transcatheter Cardiovascular Therapeutics
TCT The Coroner's Toolkit
TCT Trans Canada Trail
TCT Tcl Core Team
TCT Tsukuba College of Technology (Japan) 
 2004), in Washington D.C. (Submission # 550778).

Intracoronary infusion of adipose tissue-derived regenerative cells 48 hours after infarction was found to be safe, with all 13 swine surviving to the six-month follow-up period. Additionally, the study demonstrated a statistically significant improvement in left ventricular ejection fraction ejection fraction
n.
The blood present in the ventricle at the end of diastole and expelled during the contraction of the heart.


Ejection fraction 
 (LVEF LVEF Left ventricular ejection fraction. See Ejection fraction. ) at six-months post-infarction in the treated group over the control group, as measured by 2D echocardiography Echocardiography Definition

Echocardiography is a diagnostic test that uses ultrasound waves to create an image of the heart muscle. Ultrasound waves that rebound or echo off the heart can show the size, shape, and movement of the heart's valves and
. Similar trends were observed by measuring LVEF via cineangiography, as provided in the data table below. LVEF is a measure of the heart's ability to pump oxygenated blood Oxygenated blood
Blood carrying oxygen through the body.

Mentioned in: Patent Ductus Arteriosus
 throughout the body. It specifically determines the fraction of blood that is ejected out of the left ventricle left ventricle
n.
The chamber on the left side of the heart that receives the arterial blood from the left atrium and contracts to force it into the aorta.
 with each contraction.

"We are encouraged by the findings from this preclinical study, which suggest that delivery of autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism.

au·tol·o·gous
adj.
1.
, adipose tissue-derived, regenerative cells is safe and effective in preserving left ventricular systolic Systolic
The phase of blood circulation in which the heart's pumping chambers (ventricles) are actively pumping blood. The ventricles are squeezing (contracting) forcefully, and the pressure against the walls of the arteries is at its highest.
 function," said John K. Fraser, Vice President, Research and Technology, of MacroPore Biosurgery. "Despite the fact that this study was designed primarily to evaluate the safety of dose escalation in limited infarcts, we observed statistically significant improvements in heart function. Additional swine studies are underway to better understand and optimize dosing and efficacy in order to lay the foundation for clinical work."

MacroPore Biosurgery and other investigators from around the world have shown that adipose tissue adipose tissue (ăd`əpōs'): see connective tissue.
adipose tissue
 or fatty tissue

Connective tissue consisting mainly of fat cells, specialized to synthesize and contain large globules of fat, within a
 is a rich source of autologous regenerative cells. Adipose tissue-derived regenerative cells consist of (1) adult stem cells, (2) endothelial progenitor cells (blood vessel blood vessel
n.
An elastic tubular channel, such as an artery, a vein, a sinus, or a capillary, through which the blood circulates.


blood vessel(s),
n the network of muscular tubes that carry blood.
 forming cells) and (3) other growth factor producing cells (tissue growth and repair promoting cells). These cells have practical benefits over other sources of regenerative-capable cells such as bone marrow, skeletal muscle, embryonic and fetal tissue and rarer sources of stem cells. Additionally, regenerative cells from a patient's own adipose tissue (autologous-use) present no risk of rejection or disease transmission and avoid ethical concerns.

The methods used in the pre-clinical study are as follows: Infarcts were induced in 13 juvenile swine by balloon occlusion of the mid left anterior descending artery. Forty-eight hours after the infarction, adipose cells were harvested through a lipectomy lipectomy /lip·ec·to·my/ (li-pek´tah-me) excision of a localized area of subcutaneous adipose tissue.

suction lipectomy , suction-assisted lipectomy
, autologous regenerative cells were isolated, and the pigs were randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 to either an intracoronary infusion of saline (control) or 40-140x106 regenerative cells (experimental) infused distal to the site of occlusion. All 13 pigs survived to the six-month follow up period. Left ventricular cineangiography and 2D echocardiography were performed at baseline, immediately post-infarction, and at six-months. The table below summarizes the study results:
Diagnostic Method    LVEF at  LVEF at 6-  Change in  Standard    P-
                    Baseline   Months       LVEF     Deviation  value
----------------------------------------------------------------------
2D Echocardiography
----------------------------------------------------------------------
           Treated     46%       49%       + 3%       +/- 6%
----------------------------------------------------------------------
           Control     47%       38%       - 9%       +/- 5%     0.01
----------------------------------------------------------------------
Cineangiography
----------------------------------------------------------------------
           Treated     51%       55%       + 4%       +/- 5%
----------------------------------------------------------------------
           Control     49%       47%       - 2%       +/- 7%     0.16
----------------------------------------------------------------------



About MacroPore Biosurgery, Inc.

MacroPore Biosurgery (Frankfurt: XMP) is focused on the discovery and development of regenerative medicine technologies. We have two technology platforms, regenerative cell technology and bioresorbable technology. Within our regenerative cell technology program, we are developing a system to isolate autologous, homologous-use regenerative cells. Simultaneously, we are generating scientific knowledge through internal research to support the clinical use of these cells. Our most advanced research and development program is in the repair of cardiovascular tissues that are damaged after a heart attack. We are also researching applications in bone repair, spinal disc regeneration and, cosmetic and reconstructive surgery. Our surgical implants, derived from our bioresorbable technology, represent one of the latest advancements in spine and orthopedic medicine. For further information please visit our web site http://www.macropore.com.

Cautionary Statement Regarding Forward-Looking Statements for MacroPore Biosurgery, Inc.

This press release may include forward-looking statements regarding events and trends which may affect MacroPore Biosurgery's future operating results and financial position. Such statements are subject to risks and uncertainties that could cause MacroPore Biosurgery's actual results and financial position to differ materially. These risks and uncertainties are described (under the heading "Risk Factors") in our 2003 Form 10-K annual report for the year ended December 31, 2003, which is available on our web site. MacroPore Biosurgery assumes no responsibility to publicly release the results of any revision of forward-looking statements to reflect events, trends or circumstances after the date they are made.
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Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Sep 27, 2004
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