CYTX’s PRECISE trial for chronic myocardial ischemia has affirmed a statistically significant improvement in cardiac function at 18 months.
Adipose (fat) tissue-derived regenerative cells (ADRCs) obtained using the Celution(NYSE:R) System demonstrated a statistically significant improvement in cardiac functional capacity (MVO2) at 18 months in Cytori’s PRECISE trial for chronic myocardial ischemia. The trial demonstrated 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 6 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;
- The procedure, which includes withdrawing fat tissue, separating out the regenerative cells using CYTX’s Celution(R) 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 data, CYTX will directly seek EU regulatory approval of this treatment for no-option chronic ischemia patients.
- CYTX intends to file necessary submissions in early 2011.
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(R) 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(NYSE:TM) System, made by Biologic Delivery Systems Group, a J&J company, a 3 dimensional image was created to guide the injection of cells into the ischemic (low blood flow) regions of the heart.
Heart disease is the leading killer in the US and the EU.
- No-option chronic myocardial ischemia patients make up approximately 6% of coronary heart disease (NYSE:CHD) patients worldwide and suffer from one of the most serious conditions among heart failure patients;
- In the US, more than 1M patients are in this class, with a 10 year mortality rate exceeding 20% and an annual healthcare cost of more than $10B.
Data from this trial was presented today at the American Heart Association Scientific Sessions 2010 in Chicago by Co-Principal Investigator Emerson C. Perin, MD, PhD, Director, Clinical Research for Cardiovascular Medicine, and Medical Director, Stem Cell Center, Texas Heart Institute.
- For the record, 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.