Cytori Therapeutics announced the publication of previously reported six-month outcomes from APOLLO, the Company's European clinical trial evaluating adipose-derived stem and regenerative cells (ADRCs) in patients with acute myocardial infarction (heart attack or AMI), as Research Correspondence in the Journal of the American College of Cardiology. The APOLLO trial was a 14-patient, prospective, randomized, double-blind, placebo-controlled, feasibility trial (Phase I/IIA) evaluating autologous ADRCs extracted with the Company's proprietary Celution® System for the treatment of patients suffering from acute myocardial infarction.
In the APOLLO trial all patients were treated with standard-of-care and subsequently underwent an abdominal liposuction. Each patient's adipose tissue was processed by the Celution® System where ADRCs were extracted, washed and concentrated into a syringe of clinical grade cells. Within 36 hours of the myocardial infarction and no longer than 24 hours after undergoing percutaneous coronary intervention, patients received an injection of either 20 million ADRCs (n=10) or a placebo (n=4).
The publication reported:
o The procedure could be safely performed in an acute setting
o No side effects from ADRC delivery, processed using Celution®
o No increase in arrhythmias
o Improvement in cardiac function by SPECT
o Improvement in blood flow into the heart muscle (perfusion defect)
o Reduction in scar formation (infarct size)
"Based on both the six and 18-month outcomes, which showed continued safety and sustained long-term benefits, we initiated ADVANCE, a pivotal, prospective, randomized, double-blind, European heart attack trial in up to 360 patients," said Christopher J. Calhoun, CEO for Cytori.
"The goal of our ADRC therapy is to reduce scarring, preserve heart muscle beyond what can be salvaged with current treatments, minimize harmful remodeling, and ultimately protect patients from advancing into heart failure."
The publication, co-authored by trial investigators Drs. Henricus J. Duckers, Patrick W. Serruys, Jaco H. Houtgraaf at Thoraxcenter, Erasmus University Hospital and others, reported the following:
• The percentage of left ventricle (LV) infarcted was reduced by 52% (31.6 ± 5.3% to 15.3 ± 2.6% at six-month follow-up, p=0.002) in the ADRC-treated patients, as opposed to no change in the placebo-treated AMI patients (24.7 ± 9.2 % vs. 24.7 ± 4.1%). The difference between the groups was not statistically significant.
• There was a significant improvement of the perfusion defect in ADRC-treated patients from 16.9 ± 2.1% to 10.9 ± 2.4% at six-month follow-up (change of 6.0%, p=0.004) as compared to a deterioration in the placebo group by 1.8% (15.0 ± 4.9% to 16.8 ± 4.3%).
• Left ventricular ejection fraction (LVEF), measured by SPECT, improved with an absolute difference of +5.7% (p=0.114). In ADRC treated patients, LVEF improved by 4% (52.1% to 56.1%), as compared to a deterioration of 1.7% in the placebo group (52.0% to 50.3%).
"The advantage of adipose tissue as a cell source is that it allows physicians to get a meaningful dose of a patient's own cells at the point-of-care when using the Celution® System without cell culture or use of donor cells," said Dr. Duckers, lead author of the paper. "We believe delivering cells within the first 24 to 36 hours takes advantage of the body's signaling and initiates the repair process before irreparable damage occurs."
Cytori is currently preparing the full 18 month data set for publication.