Authors
Victoria Florea, Angela C Rieger, Darcy L DiFede, Jill El-Khorazaty, Makoto Natsumeda, Monisha N Banerjee, Bryon A Tompkins, Aisha Khan, Ivonne H Schulman, Ana Marie Landin, Muzammil Mushtaq, Samuel Golpanian, Maureen H Lowery, John J Byrnes, Robert C Hendel, Mauricio G Cohen, Krystalenia Valasaki, Marietsy V Pujol, Eduard Ghersin, Roberto Miki, Cindy Delgado, Fouad Abuzeid, Mayra Vidro-Casiano, Russell G Saltzman, Daniel DaFonseca, Lina V Caceres, Kevin N Ramdas, Adam Mendizabal, Alan W Heldman, Raul D Mitrani, Joshua M Hare
Publication date
2017/11/10
Journal
Circulation research
Volume
121
Issue
11
Pages
1279-1290
Publisher
Lippincott Williams & Wilkins
Description
Rationale:
Cell dose and concentration play crucial roles in phenotypic responses to cell-based therapy for heart failure.
Objective:
To compare the safety and efficacy of 2 doses of allogeneic bone marrow–derived human mesenchymal stem cells identically delivered in patients with ischemic cardiomyopathy.
Methods and Results:
Thirty patients with ischemic cardiomyopathy received in a blinded manner either 20 million (n=15) or 100 million (n=15) allogeneic human mesenchymal stem cells via transendocardial injection (0.5 cc per injection × 10 injections per patient). Patients were followed for 12 months for safety and efficacy end points. There were no treatment-emergent serious adverse events at 30 days or treatment-related serious adverse events at 12 months. The Major Adverse Cardiac Event rate was 20.0% (95% confidence interval [CI], 6.9% to 50.0%) in 20 million and 13.3% (95% CI, 3.5% to 43.6%) in …
Scholar articles
V Florea, AC Rieger, DL DiFede, J El-Khorazaty… - Circulation research, 2017