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APOLLO: Efficacy of ADRC therapy documented in STEMI patients
First-in-man study also established safety, feasibility of therapy.
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For patients with STEMI in the APOLLO trial, treatment with adipose tissue-derived regenerative cell therapy was able to improve global ejection fraction and reduce percentage of left ventricle infarcted and the perfusion defect, whereas those in the placebo group experienced no change or a worsening of symptoms.
APOLLO was a prospective, randomized, double blind, placebo-controlled study that enrolled patients (n=14) to evaluate the safety and feasibility in patients with STEMI of intra-coronary delivery of adipose tissue-derived regenerative cells (ADRC; Celution 800, Cytori Therapeutics). ADRC therapy employs a process that withdraws fat tissue from the abdomen, separates regenerative cells and re-injects them into the patient’s heart, which can all be completed at the patient’s bedside.
Patients were eligible for the trial if they were successfully treated for an acute MI, had no history of heart disease and presented with clinical symptoms consistent with acute MI between 2 and 12 hours from symptom onset.
Researchers reported that ADRC therapy was well tolerated and did not result in any adverse events. From baseline to 6 months, global LVEF improved in the ADRC arm (+4%) and deteriorated in the placebo arm (–1.7%), although this difference was not statistically significant. Significant improvements, however, were noted in the ADRC arm, with a 51.3% reduction in percent of LV infarcted (P<.001) and a 6% improvement in perfusion defect (P=.004). For those given placebo, no changes were reported in percent LV infarcted, whereas perfusion defect deteriorated by 1.7%.
The trial was sponsored by Cytori.
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