San Diego, Calif.-based Cytori reports that adipose (fat) tissue-derived regenerative cells (ADRCs) showed a statistically significant improvement in cardiac functional capacity at 18 months in the company’s PRECISE trial for chronic myocardial ischemia.
New data from this trial were presented at the American Heart Association Scientific Sessions by co-principal investigator Emerson C. Perin, M.D., Ph.D., medical director of the Stem Cell Center at the Texas Heart Institute.
Heart disease is the leading killer in the U.S. and Europe. No-option chronic myocardial ischemia patients make up approximately 6 percent of coronary heart disease (CHD) patients worldwide and suffer from one of the most serious conditions among heart failure patients. In the United States, more than one million patients are in this class, with a 10 year mortality rate exceeding 20 percent and an annual healthcare cost of more than $10 billion.
The trial demonstrated the following outcomes in no-option chronic ischemic heart disease patients:
– The statistically significant improvement in MVO2 (maximum oxygen consumption) in the cell treated group compared to the control group, first demonstrated at six months, is sustained at 18 months;
– The statistically significant improvement in patients’ ability to perform physical activity, as measured by metabolic equivalents (METS), in the cell treated group compared to the control group is sustained from 6 to 18 months; and
– The procedure, which includes withdrawing fat tissue, separating out the regenerative cells using Cytori’s Celution System, and re-injecting the cells into the patient’s heart, has previously been found to be safe and feasible, with no safety concerns emerging during the 18-month observation period.
– ADRC treated patients had a lower cardiac mortality rate compared to the control. At an average follow up of 28 months, 2 of 6 placebo patients died of cardiac causes whereas 1 of 21 died in the cell treated group from cardiac causes. There were 2 patient deaths from non-cardiac causes in the cell treated group.
Based on this new information, Cytori said it will directly seek EU regulatory approval of this treatment for no-option chronic ischemia patients. The company intends to file necessary submissions in early 2011.
“These are the most excellent and clinically relevant long term trial results we have indicating that the use of stem cell therapy in chronic ischemia patients is beneficial,” Perin said. “The documented improvements are important as these patients would otherwise be expected to show substantial decreases in MVO2 over time. MVO2 is a key measure for functional capacity and we are seeing a real signal that this treatment is impacting patients’ lives in this randomized blinded study.”
MVO2 (or VO2 max) is the maximum volume of oxygen that can be utilized by the heart in one minute during peak exercise. MVO2 is a clinically relevant prognostic factor for outcomes in heart disease, including mortality and transplant requirement and is commonly used as a contributing measure to stratify patients for heart transplant. METS (metabolic equivalent) is a related measure commonly used by doctors to assess how much energy a patient can exert during exercise.
The PRECISE trial is a multi-center, 27 patient, double-blind, placebo-controlled European study in patients with no-option chronic myocardial ischemia, a severe form of heart disease. As part of the procedure, a small amount of fat tissue was removed from each patient’s abdomen. Using the Celution System, stem and regenerative cells were separated from each patient’s fat tissue and concentrated at the point-of-care. 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 ischemic (low blood flow) regions of the heart.