A Critical Analysis of Clinical Outcomes Reported in Stem Cell Trials for Acute Myocardial Infarction: Some Thoughts for Design of Future Trials

  • Anita D. Szady
  • Carl J. Pepine
  • Shreela V. Sharma
  • Christopher R. Cogle
  • Emerson C. Perin
  • Stephen G. Ellis
  • Lemuel A. Moyé
  • for the Cardiovascular Cell Therapy Research Network (CCTRN)
Clinical Trials and Their Interpretation (J Plutzky, Section Editor)

DOI: 10.1007/s11883-013-0341-9

Cite this article as:
Szady, A.D., Pepine, C.J., Sharma, S.V. et al. Curr Atheroscler Rep (2013) 15: 341. doi:10.1007/s11883-013-0341-9
Part of the following topical collections:
  1. Topical Collection on Clinical Trials and Their Interpretations

Abstract

The purpose of stem cell therapy for myocardial infarction is to improve clinical outcomes, and detailed information on clinical outcomes is critical to appropriate planning of phase III trials. We have examined data from select phase II trials using autologous bone-marrow-derived stem cells in patients with acute myocardial infarction. We have extracted available definitions and outcome data, and have generated standardized estimates of events to permit summary comparisons. Nine trials (1,040 patients) with results for 6 months to 5 years were evaluated. Adverse outcomes differed widely, and there was a general lack of details in the definitions of these outcomes. Heart-failure-related hospitalizations occurred in only 16 patients (1.5 %) and death occurred in only 43 patients (4.1 %). Ischemia-related outcomes outnumbered heart failure outcomes more than tenfold. Uniform criteria need to be developed to better define clinical outcomes of interest. Furthermore, a refocus from heart failure outcomes to ischemia-related outcomes seems appropriate.

Keywords

Stem cells Acute myocardial infarction Clinical outcomes Secondary outcomes Phase II trials 

Copyright information

© Springer Science+Business Media New York 2013

Authors and Affiliations

  • Anita D. Szady
    • 1
  • Carl J. Pepine
    • 1
  • Shreela V. Sharma
    • 3
  • Christopher R. Cogle
    • 2
  • Emerson C. Perin
    • 4
  • Stephen G. Ellis
    • 5
  • Lemuel A. Moyé
    • 3
  • for the Cardiovascular Cell Therapy Research Network (CCTRN)
  1. 1.Division of Cardiovascular MedicineUniversity of Florida College of MedicineGainesvilleUSA
  2. 2.Division of Hematology & OncologyUniversity of Florida College of MedicineGainesvilleUSA
  3. 3.University of Texas School of Public HealthHoustonUSA
  4. 4.Texas Heart InstituteHoustonUSA
  5. 5.Cleveland ClinicClevelandUSA

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