Presentation Abstract

Session: CS.01-Application of Cell-Based Therapies to Treat Cardiac and Peripheral Diseases
Presentation: Intramyocardial Injection of Allogeneic Mesenchymal Precursor Cells in Left Ventricular Assist Device Patients
Pres Time: Monday, Nov 18, 2013, 9:35 AM - 9:45 AM
Location: Ballroom A1
Pres. Time: Monday, Nov 18, 2013, 9:35 AM - 9:45 AM
Specialty: Stem cells
Keywords: Stem cell therapy; Heart failure; Ventricular assist devices; NHLBI
Presenter: Deborah D Ascheim, Icahn Sch of Med at Mount Sinai, New York, NY
Abstract: BACKGROUND: Intramyocardial administration of allogeneic mesenchymal precursor cells (MPC) injected at the time of left ventricular assist device (LVAD) implantation may contribute to myocardial recovery in advanced heart failure (AHF) patients. This trial, conducted by the NIH-sponsored Cardiothoracic Surgical Trials Network (CTSN) and the Cardiovascular Cell Therapy Research Network (CCTRN), assesses the safety and explores the efficacy of intramyocardial allogeneic MPCs (Mesoblast) as an adjunct to LVAD.
METHODS: Thirty patients were randomized at 11 sites in this double-blind, sham procedure controlled trial evaluating a single intramyocardial injection of MPCs on safety, functional status, myocardial function, cardiomyocyte regeneration, and neovascularization in patients with AHF, implanted with an LVAD as bridge to cardiac transplantation (BTT) or destination therapy (DT). Patients were randomly assigned (2:1) to 25 million MPCs or medium alone. The primary safety endpoint is the incidence of infectious myocarditis, myocardial rupture, neoplasm, hypersensitivity reaction, and immune sensitization (90 days post randomization). The key efficacy endpoint is functional status and ventricular function, while weaned from LVAD support (90 days post randomization); other secondary endpoints include neurocognition, adverse events, anti-HLA antibody sensitization, cardiomyocyte regeneration, phenotypic and functional analyses, and chemo- and cytokine quantification. All patients are followed until transplant or until 12 months post randomization, whichever comes first.
RESULTS: Enrollment was completed in 15 weeks. All patients have met the primary 90 day efficacy endpoint, and investigators remain blinded to all outcomes until the last patient completes 1 yr final assessment in 08/13.
CONCLUSION: This trial will provide important information with regard to the safety and efficacy of MPC injection at the time of LVAD implantation.

Disclosures:   D.D. Ascheim: Consultant/Advisory Board; Modest; BackBeat Medical, Inc, Velomedix. Y. Naka: Consultant/Advisory Board; Modest; Thoratec Co., Transmedics Inc., Medtronics. N.G. Smidera: None. L.A. Moye: None. S. Lee: None. C.T. Klodell: None. A. Szady: None. M.K. Parides: None. N. Jeffries: None. D. Skerret: Employment; Significant; Mesoblast Ltd. Ownership Interest; Significant; Mesoblast Ltd. D.A. Taylor: Ownership Interest; Significant; Miromatrix Medical Inc. K. Margulies: None. C. Milano: None. J.G. Rogers: Consultant/Advisory Board; Modest; Thoratec. T. Dewey: None. E. Eichorn: None. B. Sun: None. D. Feldman: Consultant/Advisory Board; Modest; Thoratec - no personal funds have been received. Monies only for travel and or to the Foundation/Charity, HeartWare- no personal monies have been receive. Monies only for travel and or to the Foundation/Charity, Medtronic- no personal monies have been received. Monies only for traveland or to the Foundation/Charity., XDx- no personal monies have been receive. Monies only for travel and or to the Foundation/Charity. Research Grant; Significant; NIH, Swiss ROTF. D. Goldstein: Honoraria; Modest; Medical Advisory Board, Thoratec Inc., HeartWare, Inc. Consultant/Advisory Board; Modest; Sunshine Heart Inc. P.T. O'Gara: None. R.D. Simari: None. S. Skarlatos: None. W. Taddei-Peters: None. M. Miller: None. E. Bagiella: None. A.C. Gelijns: None. J.Y. Woo: None.
allogeneic mesenchymal precursor cells (MPC)

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