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

Journal Article (Journal Article;Multicenter Study)

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.

Full Text

Duke Authors

Cited Authors

  • Swaminathan, M; Stafford-Smith, M; Chertow, GM; Warnock, DG; Paragamian, V; Brenner, RM; Lellouche, F; Fox-Robichaud, A; Atta, MG; Melby, S; Mehta, RL; Wald, R; Verma, S; Mazer, CD; ACT-AKI investigators,

Published Date

  • January 2018

Published In

Volume / Issue

  • 29 / 1

Start / End Page

  • 260 - 267

PubMed ID

  • 29038286

Pubmed Central ID

  • PMC5748899

Electronic International Standard Serial Number (EISSN)

  • 1533-3450

Digital Object Identifier (DOI)

  • 10.1681/ASN.2016101150


  • eng

Conference Location

  • United States