@article{1e3e6fda54384d739b4e2ce895bc689f,
title = "Point of care, bone marrow mononuclear cell therapy in ischemic heart failure patients personalized for cell potency: 12-month feasibility results from CardiAMP heart failure roll-in cohort",
abstract = "Aim: Heart failure following myocardial infarction (MI) is a potentially lethal problem with a staggering incidence. The CardiAMP Heart Failure trial represents the first attempt to personalize marrow-derived cell-based therapy to individuals with cell characteristics associated with beneficial responses in prior trials. Before the initiation of the randomized pivotal trial, an open-label “roll-in cohort” was completed to ensure the feasibility of the protocol's procedures. Methods: Patients with chronic post-MI heart failure (NYHA class II-III) receiving stable, guideline-directed medical therapy with a left ventricular ejection fraction between 20 and 40% were eligible. Two weeks prior to treatment, a ~ 5 mL bone marrow aspiration was performed to examine “cell potency”. On treatment day, a 60 mL bone marrow aspiration, bone marrow mononuclear cell (BM MNC) enrichment and transendocardial injection of 200 million BM MNC's was performed in a single, point of care encounter. Patients were then followed to assess clinical outcomes. Results: The cell potency small volume bone marrow aspirate, the 60 mL bone marrow aspirate, and transendocardial injections were well tolerated in 10 patients enrolled. There were no serious adverse events related to bone marrow aspiration or cell delivery. Improvement in 6-min walk distance was observed at 6 months (+47.8 m, P = 0.01) and trended to improvement at 12 months (+46.4, P = 0.06). Similarly, trends to improved NYHA heart failure functional class, quality of life, left ventricular ejection fraction and recruitment of previously akinetic left ventricular wall segments were observed. Conclusion: All CardiAMP HF protocol procedures were feasible and well tolerated. Favorable functional, echo and quality of life trends suggest this approach may offer promise for patients with post MI heart failure. The randomized CardiAMP Heart Failure pivotal trial is underway to confirm the efficacy of this approach. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT02438306",
keywords = "Clinical trial, Heart failure, Potency, Stem cell, Therapeutics",
author = "Raval, {Amish N.} and Johnston, {Peter V.} and Duckers, {Henricus J.} and Cook, {Thomas D.} and Traverse, {Jay H.} and Altman, {Peter A.} and Ravi Dhingra and Peiman Hematti and Ivan Borrello and Anderson, {R. David} and Pepine, {Carl J.}",
note = "Funding Information: CardiAMP HF is a clinical trial funded by BioCardia Inc. , San Carlos, CA, Maryland Stem Cell Research Fund ( 2016-MSCRFP-2804 ) and Centers for Medicare and Medicaid . Funding Information: CardiAMP HF is a clinical trial funded by BioCardia Inc., San Carlos, CA, Maryland Stem Cell Research Fund (2016-MSCRFP-2804) and Centers for Medicare and Medicaid.ANR: Research support to the U. Wisconsin-Madison from Fujifilm Cellular Dynamics, BioCardia, Biologics Delivery Systems, Johnson & Johnson and Cellular Logistics Inc., NIH/NHLBI 1U01HL148690-01, NIH 5T32HL007936-15. Consultant for Cellular Logistics Inc., Blue Rock Therapeutics Inc.CJP: Research or educational support to the University of Florida-Amarin; AMGEN; Alnylam; AstraZeneca; BioCardia, Inc.; Biologic Delivery Systems, Johnson & Johnson, Brigham and Women's Hospital via NHLBI; CSL Behring; LLC & Duke University for DCRI; DoD CDMRPPR161603; Capricor Inc.; Cytori Theraputics; GE Health Care; McJunkin Family Foundation; PCORnet; Mesoblast, Inc.; NIH/NHLBI 1 R01 HL146158-01, R01 HL132448 and UM1 HL087366; Pfizer; and Sanofi US Services, Inc., Consultant-BioCardia Inc.; Caladrius Biosciences, Inc.; Imbria Pharmaceuticals, Inc.; Ironwood Pharmaceuticals, Inc.; Mesoblast, Inc.; Milestone Pharmaceuticals; Novartis Pharmaceuticals; Takeda Pharmaceutical USA, Inc.; Verily Life Sciences LLC; and XyloCor Therapeutics, Inc.HJD and PAA are employees of BioCardia.PVJ is a consultant for BioCardia, Inc., Precigen, Inc., Astra Zeneca, Inc; and Founder and Chief Technical Officer, Domicell, Inc.The authors acknowledge the outstanding contributions of the following: Adrian Gee and April Durett of the Center for Cell & Gene Therapy, Baylor College of Medicine, Texas Children's Hospital in Houston; Maria Cabreira of the Stem Cell Center, Texas Heart Institute, Houston, for their support of CardiAMP HF stem cell studies. In addition, Mary Jo Rizzo, Lavanya Bellumkonda, Lissa Sugeng, and Alexandra Lansky of the Yale Echo Core Lab, Yale Cardiovascular Research Group, New Haven CT, for the echocardiographic image analysis in the CardiAMP HF study. We acknowledge the contributions of Gary Gerstenblith MD at Johns Hopkins University School of Medicine, John Hiemenz MD and John Wingard MD at U. Florida College of Medicine for bone marrow aspiration, and Thomas Cook PhD at U. Wisconsin-Madison for Biostatistics Expertise. Publisher Copyright: {\textcopyright} 2020 The Authors",
year = "2021",
month = mar,
day = "1",
doi = "10.1016/j.ijcard.2020.10.043",
language = "English (US)",
volume = "326",
pages = "131--138",
journal = "International Journal of Cardiology",
issn = "0167-5273",
publisher = "Elsevier Ireland Ltd",
}