A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study of Intravenous Adult Human Mesenchymal Stem Cells (Prochymal) After Acute Myocardial Infarction
Joshua M. Hare, MD*,*,
Jay H. Traverse, MD ,
Timothy D. Henry, MD,
Nabil Dib, MD ,
Robert K. Strumpf, MD,
Steven P. Schulman, MD ,
Gary Gerstenblith, MD,
Anthony N. DeMaria, MD||,
Ali E. Denktas, MD¶,
Roger S. Gammon, MD#,
James B. Hermiller, Jr, MD**,
Mark A. Reisman, MD,
Gary L. Schaer, MD and
Warren Sherman, MD
* Department of Medicine, Cardiovascular Division and the Interdisciplinary Stem Cell Institute, Miller School of Medicine, University of Miami, Miami, Florida
Minneapolis Heart Institute, Minneapolis, Minnesota
Arizona Heart Institute, Phoenix, Arizona
The Johns Hopkins Hospital, Baltimore, Maryland
|| University of California San Diego, San Diego, California
¶ University of Texas Houston Medical School, Houston, Texas
# Heart Hospital of Austin, Austin, Texas
** The Care Group, LLC, Indianapolis, Indiana
Swedish Medical Center, Seattle, Washington
Rush University Medical Center, Chicago, Illinois
New York Presbyterian Hospital, New York, New York
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Figure 2 Percentage of Patients With >10 PVCs per Hour
Human mesenchymal stem cells = green line (n = 32 at 3 months, n = 33 at 6 months); placebo = red line (n = 19 at 3 months, n = 16 at 6 months). *p = 0.001 by repeated measure analysis of variance; p < 0.05 versus days 1 and 90; p = 0.017 versus placebo. PVC = premature ventricular contraction.
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Figure 3 Increase From Baseline Values in Percent LVEF at 3 and 6 Months Post-Treatment in Patients With Anterior MI
Human mesenchymal stem cells = solid bars (n = 17 at 3 months, n = 15 at 6 months); placebo = open bars (n = 10 at 3 months, n = 9 at 6 months). *p = 0.0436 at 6 months for human mesenchymal stem cell-treated patients versus baseline, analysis of variance. LVEF = left ventricular ejection fraction; MI = myocardial infarction.
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Figure 4 Impact of hMSC Treatment on LVEF Evaluated by Cardiac MRI
Human mesenchymal stem cells (hMSCs) = green line (n = 21 at 3 months, n = 18 at 6 and 12 months); placebo = red line (n = 13 at 3 months, n = 11 at 6 and 12 months). *p = 0.003 by repeated measure analysis of variance; p = 0.005 versus baseline. Abbreviations as in Figure 3.
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Figure 5 Impact of hMSC Treatment on LV Remodeling
Changes in left ventricular (LV) ejection fraction (EF) are plotted against the changes in LV end-systolic volume (ESV) (A) and end-diastolic volume (EDV) (B) during follow-up. Human mesenchymal stem cell (hMSC) patients (n = 21 at 3 months, n = 18 at 6 and 12 months) exhibit evidence of reverse remodeling with no increase in LV EDV and a decline in LV ESV, whereas placebo patients (n = 13 at 3 months, n = 11 at 6 and 12 months) demonstrate evidence of LV chamber enlargement. *p = 0.005 versus baseline.
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Figure 6 Difference From Baseline in FEV1 % Predicted
Human mesenchymal stem cells = green line (n = 31); placebo = red line (n = 18). Error bars represent standard error of the mean. *p = 0.003 by repeated measure analysis of variance; p = 0.01 versus placebo. FEV1 = forced expiratory volume in 1 s.
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Figure 7 Percentage of Patients With Improved Global Assessment
Human mesenchymal stem cells = green line; placebo = red line. *p = 0.027 between groups, Fisher exact test; p = 0.016 versus day 10, Fisher exact test.
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