Authors
Joshua M Hare, Joel E Fishman, Gary Gerstenblith, Darcy L DiFede Velazquez, Juan P Zambrano, Viky Y Suncion, Melissa Tracy, Eduard Ghersin, Peter V Johnston, Jeffrey A Brinker, Elayne Breton, Janice Davis-Sproul, John Byrnes, Richard George, Albert Lardo, Ivonne H Schulman, Adam M Mendizabal, Maureen H Lowery, Didier Rouy, Peter Altman, Cheryl Wong Po Foo, Phillip Ruiz, Alexandra Amador, Jose Da Silva, Ian K McNiece, Alan W Heldman
Publication date
2012/12/12
Journal
Jama
Volume
308
Issue
22
Pages
2369-2379
Publisher
American Medical Association
Description
Context
Mesenchymal stem cells (MSCs) are under evaluation as a therapy for ischemic cardiomyopathy (ICM). Both autologous and allogeneic MSC therapies are possible; however, their safety and efficacy have not been compared.
Objective
To test whether allogeneic MSCs are as safe and effective as autologous MSCs in patients with left ventricular (LV) dysfunction due to ICM.
Design, Setting, and Patients
A phase 1/2 randomized comparison (POSEIDON study) in a US tertiary-care referral hospital of allogeneic and autologous MSCs in 30 patients with LV dysfunction due to ICM between April 2, 2010, and September 14, 2011, with 13-month follow-up.
Intervention
Twenty million, 100 million, or 200 million cells (5 patients in each cell type per dose level) were delivered by transendocardial stem cell injection into 10 LV sites.
Main Outcome Measures
Thirty-day postcatheterization incidence of predefined treatment …
Total citations
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