Strong safety data for Cytori's Celution System

USA-based Cytori Therapeutics says that stem and regenerative cells derived from adipose tissue were found not to be linked to arrhythmias following a heart attack in a preclinical study. The findings were reported in the advance access of EuroPace, a journal of the European Society of Cardiology, as part of a Cytori-sponsored evaluation.

"This is a significant safety finding, indicating that freshly-isolated, uncultured, adipose-derived stem and regenerative cells did not promote arrhythmias after a heart attack," said Kai Pinkernell, head of research at Cytori. "The results are important to Cytori because the cells used in this study approximate the output of our bedside cell processing device, The Celution System, which is currently in clinical testing in Europe for the treatment of heart disease. Furthermore, it favorably distinguishes adipose tissue from other sources of cells used in cell therapy, some of which have been reported to potentially increase the incidence of arrhythmias."

As part of this study, adipose stem and regenerative cells or a saline control injection were administered into infarcted subjects. The improvements in ejection fraction, capillary density and perfusion defect were reported earlier, in a trial designated by Cytori as the Tulane II Study. In addition, heart rhythms were monitored throughout an eight-week period. At no point during this time was a difference in irregular heartbeats between both groups observed, indicating cell-treated animals do not show an increase in potentially fatal arrhythmias, Cytori noted.