# Intramyocardiale mesenchymale precursorcellen en LVAD-weaning: JAMA

*geplaatst 2019-03-26 · Hartfalen · JAMA · doi 10.1001/jama.2019.2341 · https://hartvaat.nl/2019/03/26/intramyocardiale-mesenchymale-precursorcellen-en-lvad-weaning-jama/*

JAMA-studie naar intramyocardiale injectie van mesenchymale precursorcellen en het succesvol tijdelijk ontwennen van LVAD-ondersteuning.

## English: Intramyocardial Injection of Mesenchymal Precursor Cells and Successful Temporary Weaning From Left Ventricular Assist Device Support in Patients With Advanced Heart Failure: A Randomized Clinical Trial.

This JAMA study of intramyocardial mesenchymal precursor cell injection in LVAD patients explored whether regenerative cell therapy can promote sufficient myocardial recovery to enable device weaning.

## Abstract (original, from the publication)

IMPORTANCE: Left ventricular assist device (LVAD) therapy improves myocardial function, but few patients recover sufficiently for explant, which has focused attention on stem cells to augment cardiac recovery. OBJECTIVE: To assess efficacy and adverse effects of intramyocardial injections of mesenchymal precursor cells (MPCs) during LVAD implant. DESIGN, SETTING, AND PARTICIPANTS: A randomized phase 2 clinical trial involving patients with advanced heart failure, undergoing LVAD implant, at 19 North American centers (July 2015-August 2017). The 1-year follow-up ended August 2018. INTERVENTIONS: Intramyocardial injections of 150 million allogeneic MPCs or cryoprotective medium as a sham treatment in a 2:1 ratio (n = 106 vs n = 53). MAIN OUTCOMES AND MEASURES: The primary efficacy end point was the proportion of successful temporary weans (of 3 planned assessments) from LVAD support within 6 months of randomization. This end point was assessed using a Bayesian analysis with a predefined threshold of a posterior probability of 80% to indicate success. The 1-year primary safety end point was the incidence of intervention-related adverse events (myocarditis, myocardial rupture, neoplasm, hypersensitivity reactions, and immune sensitization). Secondary end points included readmissions and adverse events at 6 months and 1-year survival. RESULTS: Of 159 patients (mean age, 56 years; 11.3% women), 155 (97.5%) completed 1-year of follow-up. The posterior probability that MPCs increased the likelihood of successful weaning was 69%; below the predefined threshold for success. The mean proportion of successful temporary weaning from LVAD support over 6 months was 61% in the MPC group and 58% in the control group (rate ratio [RR], 1.08; 95% CI, 0.83-1.41; P = .55). No patient experienced a primary safety end point. Of 10 prespecified secondary end points reported, 9 did not reach statistical significance. One-year mortality was not significantly different between the MPC group and the control group (14.2% vs 15.1%; hazard ratio [HR], 0.89; 95%, CI, 0.38-2.11; P = .80). The rate of serious adverse events was not significantly different between groups (70.9 vs 78.7 per 100 patient-months; difference, -7.89; 95% CI, -39.95 to 24.17; P = .63) nor was the rate of readmissions (0.68 vs 0.75 per 100 patient-months; difference, -0.07; 95% CI, -0.41 to 0.27; P = .68). CONCLUSIONS AND RELEVANCE: Among patients with advanced heart failure, intramyocardial injections of mesenchymal precursor cells, compared with injections of a cryoprotective medium as sham treatment, did not improve successful temporary weaning from left ventricular assist device support at 6 months. The findings do not support the use of intramyocardial mesenchymal stem cells to promote cardiac recovery as measured by temporary weaning from device support. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02362646.

Auteurs: Terrence M Yau, Francis D Pagani, Donna M Mancini, Helena L Chang, Anuradha Lala, Y Joseph Woo, Michael A Acker, Craig H Selzman, Edward G Soltesz, John A Kern, Simon Maltais, Eric Charbonneau, Stephanie Pan, Mary E Marks, Ellen G Moquete, Karen L O'Sullivan, Wendy C Taddei-Peters, Lydia K McGowan, China Green, Eric A Rose, Neal Jeffries, Michael K Parides, Richard D Weisel, Marissa A Miller, Judy Hung, Patrick T O'Gara, Alan J Moskowitz, Annetine C Gelijns, Emilia Bagiella, Carmelo A Milano

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Bron: JAMA, https://doi.org/10.1001/jama.2019.2341. Bijgewerkt 2026-07-03T13:27:03Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.