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:
- Safety The procedure could be safely performed in an acute setting
No side effects from ADRC delivery, processed using Celution®
No increase in arrhythmias - Feasibility
Improvement in cardiac function by SPECT
Improvement in blood flow into the heart muscle (perfusion defect)
Reduction in scar formation (infarct size)
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%).
Cytori is currently preparing the full 18 month data set for publication.