For LVAD weaning, stem cells disappoint

  • Yau TM & al.
  • JAMA
  • 26 Mar 2019

  • International Clinical Digest
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Takeaway

  • Patients with advanced heart failure undergoing left ventricular assist device (LVAD) implant were no more likely to be weaned if they received mesenchymal precursor cells (MPCs) than if they received sham.

Why this matters

  • MPC delivery to the left ventricle has been linked to improved function. 
  • A previous study of a lower MPC dose found that the cells increased likelihood of successful temporary weaning from LVAD.
  • This trial multiplied the MPC dose 6-fold, based on favorable results in a previous dosing study.

Key results

  • Primary endpoint with MPCs vs without: 61% vs 58%;
    • Rate ratio (RR), 1.08 (95% CI, 0.83-1.41);
    • P=.55.
  • Groups had similar ejection fraction, QoL, 1-year mortality, serious adverse events, time to transplant.
  • MPC group had longer time before first serious gastrointestinal bleed or epistaxis.

Study design

  • Randomized multicenter phase 2 trial (n=155).
  • Adults with advanced heart failure receiving LVAD underwent intraoperative intramyocardial injection of 150 million allogeneic MPCs vs sham. 
  • Weaning attempted at 2, 4, 6 months postop.
  • Outcome: success at temporary LVAD weaning over 6 months.
  • Funding: NIH; Canadian Institutes for Health Research.

Limitations

  • Many weanings not begun because of pump thrombosis.
  • Heterogeneous patient group.
  • Administration route may have killed some donor cells.