Trial of Hematopoietic Stem Cells in Acute Myocardial Infarction | Clinical Trial - TECAM
The goal of the trial was to evaluate three different treatment strategies involving cell therapy after reperfusion for ST-segment elevation myocardial infarction (STEMI).
Contribution to the Literature: The TECAM trial failed to show that cell therapy after reperfusion for acute myocardial infarction improves left ventricular ejection fraction.
STEMI patients who underwent successful reperfusion therapy were randomized on day 1 to intracoronary bone marrow autologous mononuclear cell injection (BMMC; n = 30), versus granulocyte-colony stimulating factor (G-CSF; n = 30), versus BMMC + G-CSF (n = 29), versus control (n = 31).
BMMC was performed on days 3 to 5. G-CSF was given at a dose of 10 µg/kg/day subcutaneously for 5 days.
- STEMI patients who underwent successful reperfusion therapy with a sirolimus-eluting stent
- Cardiogenic shock
- Mechanical complication
- Ventricular tachycardia or atrial fibrillation
- Cardiac defibrillator
- Investigational drug treatment in the last 4 weeks
- Antineoplastic drug use
- Previous treatment with transmyocardial laser revascularization
- Women of childbearing potential
- Limited life expectancy
- Active bleeding or hypercoagulability
- Renal failure
- Prior stroke
- Anticipated major surgery
- Hypersensitivity to G-CSF treatment
- Total number of enrollees: 120
- Duration of follow-up: 12 months
- Mean patient age: 54 years
- Percentage female: 3%
- Percentage diabetics: 17%
The primary outcome, change in left ventricular ejection fraction from baseline to follow-up, was 6% in the BMMC group, versus 2% in the G-CSF group, versus 4% in the BMMC + G-CSF group, versus 4% in the control group (p = 0.37).
- The change in left ventricular end-systolic volume from baseline to follow-up was -3 cc in the BMMC group, versus -7 cc in the G-CSF group, versus -2 cc in the BMMC + G-CSF group, versus 2 cc in the control group (p = 0.36).
- Any adverse event was 27% in the BMMC group, versus 33% in the G-CSF group, versus 17% in the BMMC + G-CSF group, versus 29% in the control group (p = 0.55).
Among STEMI patients who underwent successful reperfusion with a sirolimus-eluting stent, cell therapy was unable to improve left ventricular function or volume at 1 year. Cell therapy consisted of intracoronary injection of BMMCs, mobilization with G-CSF, or combination of BMMCs and G-CSF. Despite early enthusiasm, randomized trials have failed to demonstrate notable clinical benefits from cell therapy.
San Roman JA,Sánchez PL, Villa A, M et al. Comparison of Different Bone Marrow–Derived Stem Cell Approaches in Reperfused STEMI: A Multicenter, Prospective, Randomized, Open-Labeled TECAM Trial. J Am Coll Cardiol 2015;65:2372-2382.
Keywords: Acute Coronary Syndrome, Anterior Wall Myocardial Infarction, Bone Marrow, Cell- and Tissue-Based Therapy, Drug-Eluting Stents, Granulocyte Colony-Stimulating Factor, Follow-Up Studies, Granulocytes, Heart Failure, Hematopoietic Stem Cell Mobilization, Primary Prevention, Prospective Studies, Sirolimus, Stem Cells, Stents, Ventricular Function, Left
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