Cytori Therapeutics has enrolled the first two patients in a clinical trial using adipose-derived stem and regenerative cells that could assist in the treatment of heart attack.
The APOLLO trial is scheduled to be a 48-patient, randomized, placebo-controlled, dose escalation, safety and feasibility dual-center study. A dose of adipose-derived regenerative cells, or a placebo, will be delivered through an intracoronary catheter within 36 hours following the onset of a heart attack. The trial will involve four groups of 12 patients each. In each group, nine patients will receive cells and three will receive the placebo control.
Adipose-derived regenerative cells include adult stem cells, in addition to other cell types that have been shown to increase blood flow in and around damaged and oxygen deprived tissues. As a result, the cells hold potential to change the treatment of heart disease, Cytori said.
The Celution System, like other cell processing devices, makes adipose-derived regenerative cells available in real-time and enables early treatment.
For this reason, adipose-derived regenerative cells could play a critical role in limiting or reversing heart damage caused by a heart attack, said Prof. PW. Serruys, MD, PhD, principal investigator for the trial and head of the department of interventional cardiology at Thoraxcenter.
One patient has been enrolled in each trial center, Hospital Universitario Gregorio Marañón in Madrid, Spain, and Thoraxcenter, Erasmus Medical Center in Rotterdam, The Netherlands.
Cytori said it is the sole sponsor of the APOLLO clinical trial.