Cytori Therapeutics reported sustained benefits at 18 months follow-up from its US APOLLO trial for acute myocardial infarction (AMI).
The results from the 14 patient, randomised, placebo-controlled, double-blind safety and feasibility trial demonstrated:
- Mean reduction in infarct size at 6 months was preserved at 18 months for the cell treated group (standard-of-care plus cells), at 11.7% and 11.2%, respectively. In contrast, patients receiving control (standard-of-care plus placebo), exhibited diminished treatment effect from 6 months (6.1%) to 18 months (4.4%) (see Figure 1);
- The mean reduction in left ventricular infarct size (reduction in the portion of the heart damaged by the heart attack) was statistically significant (p
- Statistically significant (p
- There were substantially fewer premature ventricular beats (PVBs) per holter recording in patients who had received cells compared to those who had received control (mean of 24 and 146 PVBs per recording, respectively).
“There is a strong correlation between infarct size and clinical outcomes,” said Henricus Duckers, co-principal investigator, interventional cardiologist, head of Molecular Cardiology, Thoraxcenter, Erasmus University Hospital. “The APOLLO data demonstrate there was a persistent beneficial effect from the cells that we believe if repeated in the ADVANCE trial should translate into superior outcomes for patients. This is very encouraging for the field of cardiac cell therapy given that this is one of the first randomised and double-blind trials to demonstrate sustained improvement in outcomes in heart attack patients as far out as 18 months.”
“Heart disease has been the leading killer for more than 100 years and is one of the greatest financial burdens on the healthcare system,” said Christopher J Calhoun, chief executive officer for Cytori. “Reductions of this magnitude in infarct size, if shown to be reproducible in a larger trial would beneficially impact long-term outcomes for patients including major adverse cardiac or coronary events, the development of chronic ischemia and death. While APOLLO was a safety and feasibility trial, Cytori’s larger European trial ADVANCE is designed to demonstrate efficacy, economic impact and the long-term benefit in patient outcomes in up to 370 patients.”
Cardiac cell therapy
As part of this novel procedure, a small amount of fat tissue was removed from each patient’s abdomen via liposuction shortly after his or her heart attack. Using a proprietary medical device, the Celution system (Cytori), stem and regenerative cells were rapidly separated from each patient’s fat tissue and concentrated at the point-of-care, in the catheter laboratory. The cells were then immediately prepared and infused into the patient’s coronary artery. All patients were treated within one day after the successful revascularisation of the infarcted artery that caused the heart attack.
As previously reported, the procedure was found to be safe. There were no new major adverse cardiac or coronary events reported between the six and 18 month follow-up. Two major adverse cardiac or coronary events were reported between baseline and the six month follow up, neither of which was attributed to the procedure. Additionally, at the time of injection, no effect on TIMI flow or coronary flow reserve was noted during and after infusion of cells or placebo, suggesting little or no micro-vascular obstruction by the infused cells.
The APOLLO trial is led by co-principal investigators Patrick W Serruys, professor of Interventional Cardiology at the Thoraxcenter, Erasmus University Hospital and Duckers. Francisco F Avilés, professor of Medicine and Chief of Department of Cardiology at Hospital General Universitario Gregorio Marañón in Madrid also participated in this trial.
European ADVANCE trial
Cytori is currently enrolling patients in the pivotal ADVANCE trial in Europe, designed to treat the same ST-elevation acute heart attack patients as in the APOLLO trial. ST-elevation heart attacks are a severe form of heart attack in which blood supply is cut off from the heart for a prolonged period of time, impacting a large portion of the heart muscle. Approximately 1.3 million patients in the United States and 1.9 million in Europe suffer from acute heart attacks each year.