MacroPore Biosurgery, Inc. (Frankfurt: XMP) today announced that adipose tissue-derived regenerative cells improved heart function following myocardial infarction 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 presentation at the Transcatheter Cardiovascular Therapeutics 2004 meeting in Washington D.C. (Abstract # 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 6-month follow-up period. Additionally, the study demonstrated a statistically significant improvement in left ventricular ejection fraction (LVEF) at six-months post-infarction in the treated group over the control group, as measured by 2D echocardiography. 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 throughout the body. It specifically determines the fraction of blood that is ejected out of the left ventricle with each contraction.
"We are encouraged by the findings from this preclinical study, which suggest that delivery of autologous, adipose tissue-derived, regenerative cells is safe and effective in preserving left ventricular systolic 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."
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