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DCM Support: cell therapy and circulatory support for dilated cardiomyopathy patients with severe ventricular

Alice Reid1,2,3, Mohsin Hussain1, Jessry Veerapen2

  • 1Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, UK.

ESC Heart Failure
|May 16, 2023
PubMed

Insights

This study investigated using a circulatory support device during cell therapy for dilated cardiomyopathy (DCM). The novel approach aims to improve safety and efficacy in patients with severely reduced ejection fraction.

Area of Science:

  • Cardiology
  • Regenerative Medicine
  • Clinical Trials

Background:

  • Dilated cardiomyopathy (DCM) significantly impairs left ventricular ejection fraction (LVEF).
  • Current therapies offer limited improvement for severely affected patients.
  • Intracoronary cell therapy shows promise but requires safe delivery methods.

Purpose of the Study:

  • To assess the safety and efficacy of intracoronary autologous bone-marrow-derived mononuclear cell infusion.
  • To evaluate the use of a percutaneous circulatory support device (Impella CP) during the procedure.
  • To improve outcomes in patients with DCM and severely reduced LVEF.

Main Methods:

  • Phase II, single-arm, single-site trial (NCT03572660) enrolling 20 DCM patients (LVEF ≤ 35%).
  • Patients received granulocyte colony-stimulating factor therapy followed by bone marrow aspiration.
  • Autologous cells were infused intracoronary, supported by Impella CP for hemodynamic stability.

Main Results:

  • Primary endpoint: Change in LVEF from baseline at 3 months.
  • Secondary endpoints: LVEF at 12 months, exercise capacity, NYHA class, quality of life, and NT-proBNP levels.
  • Safety endpoints: Procedural safety and major adverse cardiac events at 3 and 12 months.

Conclusions:

  • This is the first trial combining cytokine therapy, autologous cell infusion, and circulatory support for severe left ventricular impairment.
  • This novel approach may benefit DCM patients with the greatest need.
  • Further research is warranted to confirm safety and efficacy.
Abstract

Keywords:
Cell therapyClinical trial, circulatory supportDilated cardiomyopathyHeart failure

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