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Preclinical safety study shows adipose-derived stem cells improve heart function after heart attack

eart 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
'"/>

Contact: Tom Baker
tbaker@macropore.com
858-232-7234
Cytori Therapeutics
27-Sep-2004


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