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Mesenchymal stem cell therapy following acute MI - Mesenchymal stem cell therapy following acute MI
Description:
The goal of the trial was to evaluate the safety and efficacy of different doses of allogeneic bone-marrow derived mesenchymal stem cell (MSC) therapy compared with placebo in post-acute myocardial infarction (MI) patients.
Study Design
Patients Enrolled: 53
Mean Follow Up: 6 months
Mean Patient Age: Mean age, 57 years
Patient Populations:
Age 21-85 years, first MI 1-10 days prior to randomization, patent infarct-related artery, global left ventricular systolic dysfunction with an ejection fraction of 30%-60%, hemodynamically stable for ≥24 hours prior to randomization, elevation of >2 times upper limit of normal of creatine kinase-myocardial band or troponin during initial hospitalization for the index MI, and Karnofsky performance status score of ≥60
Primary Endpoints:
Treatment of urgent serious adverse events
Drug/Procedures Used:
Within 3-10 days of acute MI, patients were randomized to one of three escalating doses of MSC (0.5, 1.6 or 5 x 106 hMSCs/kg; n = 34) or placebo (n = 19). Continuous Holter monitors were placed on patients.
Principal Findings:
Mean ejection fraction at baseline was 50%. Approximately half of the patients in the trial had an anterior MI.
Need for at least one rehospitalization occurred in 23.5% of the MSC group and 31.6% of the placebo group. The mean number of rehospitalizations per patient was 0.26 for the MSC group and 0.37 for the placebo group. The average number of adverse events was 5.3 in the MSC group and 7.0 in the placebo group.
Arrhythmia adverse events occurred in 8.8% of the MSC group and 36.8% of the placebo group. The mean number of premature ventricular contractions (PVCs) per day was lower in the MSC group than the placebo group, as was the number of patients with >10 PVC/hour. Improvements in forced expiratory volume 1 (FEV1) occurred significantly more often in the MSC group compared with the placebo group. There was no difference in left ventricular ejection fraction between MSC and placebo groups at 6 months. There was no dose relationship observed for the varying doses of MSC.
Interpretation:
Among post-acute MI patients, infusion of allogeneic bone-marrow derived MSCs was not associated with an increase in adverse events compared with placebo.
The safety profile of the MSC infusion appeared acceptable, with no increase in adverse events, including arrhythmic adverse events and improvements in pulmonary function. Based on these data, larger studies are planned to more fully evaluate efficacy.
References:
Hare JM, Traverse JH, Henry TD, et al. A randomized, double-blind, placebo-controlled, dose-escalation study of intravenous adult human mesenchymal stem cells (prochymal) after acute myocardial infarction. J Am Coll Cardiol. 2009 Dec 8;54(24):2277-86.
Presented by Dr. Joshua Hare at the i2 Summit/American College of Cardiology Annual Scientific Session, New Orleans, LA, March 2007.
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