FOR RELEASE: 2 P.M. (CT) MONDAY, NOVEMBER 5, 2012
Joshua M. Hare, M.D., of the University of Miami Miller School of Medicine, and colleagues conducted a study to examine whether allogeneic (taken from a different individual) mesenchymal stem cells (MSCs) are as safe and effective as autologous (donor and recipient are the same person) MSCs in patients with left ventricular dysfunction due to ischemic cardiomyopathy.
“Mesenchymal stem cells are under evaluation as a therapy for ischemic cardiomyopathy (ICM),” according to background information in the article. Both autologous and allogeneic therapies are possible; however, their safety and efficacy have not been compared. “One potential advantage of allogeneic cells is the possibility of their use as an ‘off-the-shelf’ therapeutic agent, avoiding the need for bone marrow aspiration and tissue culture delays before treatment. It is also hypothesized that the function of autologous MSCs could be impaired in patients with comorbidities [other illnesses] or advanced age.”
The randomized study included a comparison of allogeneic and autologous MSCs in 30 patients with LV dysfunction due to ICM between April 2010 and September 2011, with 13-month follow-up. 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.
The researchers found that in this early-stage study of patients with ICM, “transendocardial injection of allogeneic and autologous MSCs without a placebo control were both associated with low rates of treatment-emergent serious adverse events, including immunologic reactions” and that, “in aggregate, MSC injection favorably affected patient functional capacity, quality of life and ventricular modeling.”
(doi:10.1001/jama. 2012.25321;. Available pre-embargo to the media at http://media.jamanetwork.com)
Media Advisory: This study is being released early online to coincide with its presentation at the American Heart Association’s Scientific Sessions. To contact Joshua M. Hare, M.D., call Lisa Worley at 305-243-5184 or email LWorley2@med.miami.edu.
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