Clinical InvestigationHeart FailureAdipose-derived regenerative cells in patients with ischemic cardiomyopathy: The PRECISE Trial
Section snippets
Study design
This was a prospective, randomized, placebo-controlled, double-blind, safety and feasibility study designed to enroll up to 36 patients at 4 clinical sites (online Appendix Supplementary material). The study was approved by the institutional review boards at all participating sites and was conducted according to the Declaration of Helsinki and ICH E6 Good Clinical Practice Guidelines (ClinicalTrials.gov identifier: NCT00426868). Written informed consent was obtained from all patients before
Study population
Between January 2007 and May 2009, 27 patients (average age, 63.6 ± 7.5 years; 21 men [78%]) were enrolled at the 4 study sites: 21 ADRC-treated patients and 6 control patients. Most baseline characteristics were similar between the groups, but patients in the treatment group were older and had higher diastolic blood pressure (Table I).
Cell preparation and injections
Adipose tissue was successfully harvested from all patients (mean volume, 361 ± 122 mL). The ADRCs were prepared successfully from each patient; the average ADRC
Discussion
In this multicenter, randomized, placebo-controlled, double-blind study, we have shown for the first time that the harvest and transendocardial injection of ADRCs are safe and feasible in no-option patients with ischemic cardiomyopathy. Moreover, cell therapy with ADRCs in these patients may preserve functional capacity over time and could exert a modest beneficial effect on myocardial perfusion, scar size, and left ventricular contractility.
Adipose tissue comprises a mixed cell source
Conclusion
Our findings indicate that obtaining autologous ADRCs via liposuction and delivering them by transendocardial injection are safe and feasible in patients with ischemic cardiomyopathy. Moreover, our trial provides a sound basis for testing the efficacy of ADRC therapy in a larger group of patients with chronic myocardial ischemia.
Disclosures
Dr Perin receives consulting fees from Cytori Therapeutics, Inc.
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