The first clinical trial of adipose (fat) tissue-derived stem and regenerative cells for the treatment of heart attacks showed a substantial reduction in the size of injury to the heart, an improvement in the amount of blood supply to the heart muscle, and a corresponding functional improvement in the amount of blood the heart can pump. Based on positive safety and feasibility outcomes, and the biological, physiological and functional effects from this pilot study, plans are underway by Cytori Therapeutics (NASDAQ: CYTX), the trial sponsor, to initiate a European medical device approval study for the Celution® System, the cell processing system used in the study. More detailed information on this study and the results from a separate study in chronic heart disease patients may be found at the following link: cytoritx.presslift.com/cardiacdata.
“Improvements in infarct size, perfusion and ejection fraction are reflective of improvement in the overall cardiovascular health of a patient”
Six-month results from the 14 patient, double-blind, placebo controlled study, referred to as the APOLLO trial, were reported today by Henrickus J. Duckers, M.D., Ph.D., Interventional Cardiologist, Head of Molecular Cardiology, Thoraxcentre, Erasmus University Hospital and co-Principal Investigator for the trial, at the 7th International Symposium on Stem Cell Therapy & Cardiovascular Innovation in Madrid, Spain. Highlights of the study's six month outcomes are as follows:
"Improvements in infarct size, perfusion and ejection fraction are reflective of improvement in the overall cardiovascular health of a patient," said Dr. Duckers. "Infarct size in particular, based on emerging consensus by the medical community and literature, is what we believe to be the most important predictor of re-hospitalization for heart failure, subsequent infarct, and death. The outcomes from this study are very exciting and warrant moving into a pivotal trial for European approval."
"The clinical data from APOLLO is consistent with Cytori's comprehensive preclinical data, reinforcing that improved blood flow and reduction of infarct size are how these cells are believed to impart benefit," said Marc H. Hedrick, M.D., president of Cytori. "Compared to other cell sources, adipose tissue, using the Celution® System, is the only approach whereby a patient can access a meaningful number of their own cells at the point-of-care. This is especially critical for heart attack patients, where successful outcomes are dependent on immediate coronary intervention."
As part of the novel procedure, a small amount of fat tissue was removed from each patient's abdomen shortly after his or her heart attack. Using a proprietary medical device, the Celution® System, developed by Cytori, stem and regenerative cells were quickly separated from each patient's fat tissue and concentrated at the point-of-care in the catheter laboratory. The cells were then immediately injected into the patient's coronary artery. Liposuction, processing, and cell delivery all took place within the same procedure.
The APOLLO study is led by co-Principal Investigators Patrick W. Serruys, MD, PhD, Professor of Interventional Cardiology at the Thoraxcentre, Erasmus University Hospital and Henrickus J. Duckers, M.D., Ph.D., Interventional Cardiologist, Head of Molecular Cardiology, Thoraxcentre, Erasmus University Hospital. Hospital General Universitario Gregorio Marañón in Madrid, led by Francisco F. Avilés M.D., PhD, Professor of Medicine and Chief of Department of Cardiology, also participated in this study.
"We would like to thank the patients, the investigators, and all who collaborated with us on this trial," added Alex Milstein, M.D., Vice President of Clinical Development at Cytori. "We are working closely with our Notified Body in Europe to finalize the design and protocol for a pivotal heart attack study, which we expect to initiate in late 2010 to early 2011. This will be a European approval study that is expected to range in size from 150 to 250 patients."