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Mesenchymal precursor cells as adjunctive therapy in recipients of contemporary left ventricular assist devices.

ABSTRACT: Allogeneic mesenchymal precursor cells (MPCs) injected during left ventricular assist device (LVAD) implantation may contribute to myocardial recovery. This trial explores the safety and efficacy of this strategy.In this multicenter, double-blind, sham-procedure controlled trial, 30 patients were randomized (2:1) to intramyocardial injection of 25 million MPCs or medium during LVAD implantation. The primary safety end point was incidence of infectious myocarditis, myocardial rupture, neoplasm, hypersensitivity reaction, and immune sensitization (90 days after randomization). Key efficacy end points were functional status and ventricular function while temporarily weaned from LVAD support (90 days after randomization). Patients were followed up until transplant or 12 months after randomization, whichever came first. Mean age was 57.4 (±13.6) years, mean left ventricular ejection fraction was 18.1%, and 66.7% were destination therapy LVADs. No safety events were observed. Successful temporary LVAD weaning was achieved in 50% of MPC and 20% of control patients at 90 days (P=0.24); the posterior probability that MPCs increased the likelihood of successful weaning was 93%. At 90 days, 3 deaths (30%) occurred in control patients, and none occurred in MPC patients. Mean left ventricular ejection fraction after successful wean was 24.0% (MPC=10) and 22.5% (control=2; P=0.56). At 12 months, 30% of MPC patients and 40% of control patients were successfully temporarily weaned from LVAD support (P=0.69), and 6 deaths (30%) occurred in MPC patients. Donor-specific HLA sensitization developed in 2 MPC and 3 control patients and resolved by 12 months.In this preliminary trial, administration of MPCs appeared to be safe, and there was a potential signal of efficacy. Future studies will evaluate the potential for higher or additional doses to enhance the ability to wean LVAD recipients off support.http://www.clinicaltrials.gov. Unique identifier: NCT01442129.

SUBMITTER: Ascheim DD

PROVIDER: S-EPMC4243683 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature

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Mesenchymal precursor cells as adjunctive therapy in recipients of contemporary left ventricular assist devices.

Ascheim Deborah D DD Gelijns Annetine C AC Goldstein Daniel D Moye Lemuel A LA Smedira Nicholas N Lee Sangjin S Klodell Charles T CT Szady Anita A Parides Michael K MK Jeffries Neal O NO Skerrett Donna D Taylor Doris A DA Rame J Eduardo JE Milano Carmelo C Rogers Joseph G JG Lynch Janine J Dewey Todd T Eichhorn Eric E Sun Benjamin B Feldman David D Simari Robert R O'Gara Patrick T PT Taddei-Peters Wendy C WC Miller Marissa A MA Naka Yoshifumi Y Bagiella Emilia E Rose Eric A EA Woo Y Joseph YJ

Circulation 20140328 22

<h4>Background</h4>Allogeneic mesenchymal precursor cells (MPCs) injected during left ventricular assist device (LVAD) implantation may contribute to myocardial recovery. This trial explores the safety and efficacy of this strategy.<h4>Methods and results</h4>In this multicenter, double-blind, sham-procedure controlled trial, 30 patients were randomized (2:1) to intramyocardial injection of 25 million MPCs or medium during LVAD implantation. The primary safety end point was incidence of infectio ...[more]

PMID: 24682346

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Project description:Importance:Left ventricular assist devices (LVADs) are widely used both as a bridge to heart transplant and as destination therapy in advanced heart failure. Although heart failure is common in patients with end-stage renal disease (ESRD), little is known about outcomes after LVAD implantation in this population. Objective:To determine the utilization of and outcomes associated with LVADs in nationally representative cohorts of patients with and without ESRD. Design, Setting and Participants:We described LVAD utilization and outcomes among Medicare beneficiaries after ESRD onset (defined as having received maintenance dialysis or a kidney transplant) from 2003 to 2013 based on Medicare claims linked to data from the United States Renal Data System (USRDS), a national registry for ESRD. We compared Medicare beneficiaries with ESRD to a 5% sample of Medicare beneficiaries without ESRD. Exposures:ESRD (vs no ESRD) among patients who underwent LVAD placement. Main Outcomes and Measures:The primary outcome was survival after LVAD placement. Results:Among the patients with ESRD, the mean age was 58.4 (12.1) years and 62.0% (96) were male. Among those without ESRD, the mean age was 62.2 (12.6) years and 75.1% (196) were male. From 2003 to 2013, 155 Medicare beneficiaries with ESRD (median and interquartile range [IQR] days from ESRD onset to LVAD placement were 1655 days [453-3050 days]) and 261 beneficiaries without ESRD in the Medicare 5% sample received an LVAD. During a median follow-up of 762 days (IQR, 92-3850 days), 127 patients (81.9%) with and 95 (36.4%) without ESRD died. more than half of patients with ESRD (80 [51.6%]) compared with 11 (4%) of those without ESRD died during the index hospitalization. The median time to death was 16 days (IQR 2-447 days) for patients with ESRD compared with 2125 days (IQR, 565-3850 days) for those without ESRD. With adjustment for demographics, comorbidity and time period, patients with ESRD had a markedly increased adjusted risk of death (hazard ratio, 36.3; 95% CI, 15.6-84.5), especially in the first 60 days after LVAD placement. Conclusions and Relevance:Patients with ESRD at the time of LVAD placement had an extremely poor prognosis, with most surviving for less than 3 weeks. This information may be crucial in supporting shared decision-making around treatments for advanced heart failure for patients with ESRD.

Dataset Information

Mesenchymal precursor cells as adjunctive therapy in recipients of contemporary left ventricular assist devices.

Publications

Mesenchymal precursor cells as adjunctive therapy in recipients of contemporary left ventricular assist devices.

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