Cytori has reported that the first clinical trial of adipose (fat) tissue-derived stem and regenerative cells (ADRCs) for the treatment of no-option chronic heart disease patients showed that the procedure was safe and feasible, demonstrated a statistically significant improvement in maximum oxygen consumption (MVO2). Patients’ aerobic capacity was measured as metabolic equivalents (METS) and reduced the extent of infarct size in the left ventricle.
Stem and regenerative cells were prepared and made available at the point-of-care using the Celution System, the cell processing device developed by trial sponsor Cytori Therapeutics.
Cytori said that the study, referred to as the Precise trial, is a multi-center 27 patient, double-blind, placebo-controlled, dose-escalation European study in patients with chronic myocardial ischemia, a severe form of heart disease. Primary six-month outcomes from the study were presented at the 7th International Symposium on Stem Cell Therapy & Cardiovascular Innovation in Madrid, Spain.
As part of the procedure, a small amount of fat tissue was removed from each patient’s abdomen. Using the proprietary Celution System, stem and regenerative cells were quickly separated from each patient’s fat tissue and concentrated at the point-of-care while the patients were prepared for catheterization and injection.
Immediately thereafter, using the NOGA System, made by Biologic Delivery Systems Group, a J&J company, a three dimensional image was created to guide the injection of cells into the injured (ischemic) regions of the heart. The six-month analysis was performed by combining the outcomes of all of the cell treated patients in the study. Further evaluation is being performed on all patients at 12 and 18 months as well as by comparing high and low cell dose cohorts.
Marc Hedrick, president of Cytori, said: “Cytori is extremely appreciative to the patients who participated as well as to the investigators and hospital staff. As additional data are compiled from Precise, we will incorporate the findings into the design and protocol of a planned chronic heart disease pivotal study to be funded by Cytori or a partner.”