Trial of Hematopoietic Stem Cells in Acute Myocardial Infarction | Clinical Trial - TECAM

Jun 01, 2015
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Plan Nacional de Investigacion Cientifica
Original Posted Date:
06/01/2015
References

Description:

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.

Study Design

  • Randomized
  • Parallel

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.

Inclusion criteria:

  • STEMI patients who underwent successful reperfusion therapy with a sirolimus-eluting stent

Exclusion criteria:

  • 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%

Principal Findings:

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).

Secondary outcomes:

  • 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).

Interpretation:

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.

References:

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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