The APOLLO Clinical trial is derived from its longer title: A Randomized Clinical Trial of Adipose-derived Stem cells in the Treatment of Patients with ST-elevation myocardial Infarction. The APOLLO trial is being funded by the National Institutes of Health and Cytori Therapeutics. The study participants are Alexander Milstein MD at Cytori Therapeutics, Patrick Serruys MD PhD at Erasmus University Medical Centrum in Rotterdam, Netherlands, and Hospital General Universitario Gregorio Maranon in Madrid, Spain. Goal of this clinical trial is to test the efficacy and safety of adipose tissue-derived stem cells to improve the heart function of patients that have experienced a heart attack.
14 patients were initially enrolled in the APOLLO trial and it is a randomized, placebo-based, double-blind safety and feasibility trial (Phase I/IIA) that uses a patient’s own fat-based stem cells that have been isolated from liposuction aspirates. Recently, the six-month outcomes of this experiment were published in Journal of the American College of Cardiology.
All patients in the APOLLO trial had experienced a heart attack and underwent liposuction of abdominal fat. Each patient’s fat cells were processed by the Celution System. This system extracted the stem cells from the surrounding fat cells and concentrated them into a syringe of clinical grade cells. All patients were treated within 36 hours after the heart attacks and 10 patients received an injection of 20 million Adipose-Derived Regenerative Cells and 4 of them received a placebo.
The findings are encouraging. There were no side effects from the stem cell treatments, and no increase in cardiac arrhythmias. Patients that had received the stem cells showed improvement in cardiac function as ascertained by single-photon emission computed tomography SPECT, Furthermore, stem cell-treated patients showed improved blood flow into the heart, and an 11% decrease in the size of the heart scar. Also, these positive results were also seen in the 18-month examination as well. Those patients that received the placebo showed no such improvements.
Cytori CEO, Christopher J. Calhoun said, “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. 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.”
Dr. Henricus J. Duckers, lead author of the paper, added, “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. 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.”