Allogeneic Mesenchymal Stem Cells for Treatment of AKI after Cardiac Surgery.

Autor:	Swaminathan M; Division of Cardiothoracic Anesthesiology, Department of Anesthesiology, Duke University School of Medicine, Durham, North Carolina., Stafford-Smith M; Division of Cardiothoracic Anesthesiology, Department of Anesthesiology, Duke University School of Medicine, Durham, North Carolina., Chertow GM; Department of Medicine (Nephrology), Stanford University, Stanford, California., Warnock DG; Division of Nephrology, Department of Medicine and., Paragamian V; AlloCure Inc., Burlington, Massachusetts., Brenner RM; AlloCure Inc., Burlington, Massachusetts., Lellouche F; Department of Anesthesiology and Critical Care Medicine, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Laval University, Quebec City, Quebec, Canada., Fox-Robichaud A; Division of Critical Care, Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada., Atta MG; Division of Nephrology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland., Melby S; Division of Cardiothoracic Surgery, Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama., Mehta RL; Division of Nephrology, Department of Medicine, University of California, San Diego, California; and., Wald R; Division of Nephrology and Li Ka Shing Knowledge Institute of St. Michael's Hospital., Verma S; Department of Surgery, Division of Cardiac Surgery, Keenan Research Centre for Biomedical Science and Li Ka Shing Knowledge Institute of St. Michael's Hospital, and., Mazer CD; Department of Anesthesia, Keenan Research Centre for Biomedical Science and Li Ka Shing Knowledge Institute of St. Michael's Hospital, University of Toronto, Toronto, Ontario mazerd@smh.ca.
Jazyk:	angličtina
Zdroj:	Journal of the American Society of Nephrology : JASN [J Am Soc Nephrol] 2018 Jan; Vol. 29 (1), pp. 260-267. Date of Electronic Publication: 2017 Oct 16.
DOI:	10.1681/ASN.2016101150
Abstrakt:	AKI after cardiac surgery remains strongly associated with mortality and lacks effective treatment or prevention. Preclinical studies suggest that cell-based interventions may influence functional recovery. We conducted a phase 2, randomized, double-blind, placebo-controlled trial in 27 centers across North America to determine the safety and efficacy of allogeneic human mesenchymal stem cells (MSCs) in reducing the time to recovery from AKI after cardiac surgery. We randomized 156 adult subjects undergoing cardiac surgery with evidence of early AKI to receive intra-aortic MSCs (AC607; n =67) or placebo ( n =68). The primary outcome was the time to recovery of kidney function defined as return of postintervention creatinine level to baseline. The median time to recovery of kidney function was 15 days with AC607 and 12 days with placebo (25th, 75th percentile range, 10-29 versus 6-21, respectively; hazard ratio, 0.81; 95% confidence interval, 0.53 to 1.24; P =0.32). We did not detect a significant difference between groups in 30-day all-cause mortality (16.7% with AC607; 11.8% with placebo) or dialysis (10.6% with AC607; 7.4% with placebo). At follow-up, 12 patients who received AC607 and six patients who received placebo had died. Rates of other adverse events did not differ between groups. In these patients with AKI after cardiac surgery, administration of allogeneic MSCs did not decrease the time to recovery of kidney function. Our results contrast with those in preclinical studies and provide important information regarding the potential effects of MSCs in this setting. (Copyright © 2018 by the American Society of Nephrology.)
Databáze:	MEDLINE
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