RT Journal Article
T1 Adipose-derived regenerative cells in patients with ischemic cardiomyopathy: The PRECISE Trial.
A1 Perin, Emerson C.
A1 Sanz Ruiz, Ricardo
A1 Sánchez, Pedro I.
A1 Lasso Vázquez, José María
A1 Pérez Cano, Rosa
A1 Alonso Farto, Juan Carlos
A1 Pérez David, Esther
A1 Fernández Santos, María Eugenia
A1 Fernández-Avilés Díaz, Francisco Jesús
AB Aims: Adipose-derived regenerative cells (ADRCs) can be isolated from liposuction aspirates and prepared as fresh cells for immediate administration in cell therapy. We performed the first randomized, placebo-controlled, double-blind trial to examine the safety and feasibility of the transendocardial injections of ADRCs in no-option patients with ischemic cardiomyopathy.Methods and results: Procedural, postoperative, and follow-up safety end points were monitored up to 36 months. After baseline measurements, efficacy was assessed by echocardiography and single-photon emission computed tomography (6, 12, and 18 months), metabolic equivalents and maximal oxygen consumption (MVO2) (6 and 18 months), and cardiac magnetic resonance imaging (6 months). We enrolled 21 ADRC-treated and 6 control patients. Liposuction was well tolerated, ADRCs were successfully prepared, and transendocardial injections were feasible in all patients. No malignant arrhythmias were seen. Adverse events were similar between groups. Metabolic equivalents and MVO2 values were preserved over time in ADRC-treated patients but declined significantly in the control group. The difference in the change in MVO2 from baseline to 6 and 18 months was significantly better in ADRC-treated patients compared with controls. The ADRC-treated patients showed significant improvements in total left ventricular mass by magnetic resonance imaging and wall motion score index. Single-photon emission computed tomography results suggested a reduction in inducible ischemia in ADRC-treated patients up to 18 months.Conclusion: Isolation and transendocardial injection of autologous ADRCs in no-option patients were safe and feasible. Our results suggest that ADRCs may preserve ventricular function, myocardial perfusion, and exercise capacity in these patients.
PB Elsevier
SN 0002-8703
YR 2014
FD 2014
LK https://hdl.handle.net/20.500.14352/131604
UL https://hdl.handle.net/20.500.14352/131604
LA eng
NO Perin, E. C., Sanz-Ruiz, R., Sánchez, P. L., Lasso, J., Pérez-Cano, R., Alonso-Farto, J. C., Pérez-David, E., Fernández-Santos, M. E., Serruys, P. W., Duckers, H. J., Kastrup, J., Chamuleau, S., Zheng, Y., Silva, G. V., Willerson, J. T., & Fernández-Avilés, F. (2014). Adipose-derived regenerative cells in patients with ischemic cardiomyopathy: The PRECISE Trial. American heart journal, 168(1), 88–95.e2. https://doi.org/10.1016/j.ahj.2014.03.022
DS Docta Complutense
RD 17 mar 2026