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."
MacroPore Biosurgery and other investigators from around the world have shown that adipose tissue 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 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, autologous regenerative cells were isolated, and the pigs were randomized to either an intracoronary infusion of saline (control) or 40-140x106 (mean 67.5x106) regenerative cells (experimental) infused distal to the site of occlusion. All 13 pigs (7 experimental, 6 control), survived to the 6-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:
2D Echocardiography
LVEF at Baseline
Treated = 46%
Control = 47%
LVEF at 6-Months
Treated = 49%
Control = 38%
Change in LVEF
Treated = + 3%
Control = - 9%
Standard Deviation
Treated = + 6%
Control = + 5%
P-value = 0.01
Cineangiography
LVEF at Baseline
Treated = 51%
Control = 49%
LVEF at 6-Months
Treated = 55%
Control = 47%
Change in LVEF
Treated = + 4%
Control = - 2%
Standard Deviation
Treated = + 5%
Control = + 7%
P-value = 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.