Myocardial Regeneration by Intracoronary Infusion of Selected Population of Stem Cells in Acute Myocardial Infarction - REGENT

Sep 02, 2008
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Date Presented:
01/01/2008
Date Published:
01/01/2009
Date Updated:
09/02/2008
Original Posted Date:
09/02/2008
References

Description:

The goal of the trial was to evaluate treatment with intracoronary injection of bone marrow–derived stem cells, compared with control, among patients with acute myocardial infarction (MI).

Hypothesis:

Bone marrow–derived stem cells will improve left ventricular ejection fraction (LVEF).

Study Design

Patients Enrolled: 200
Mean Follow Up: 6 months
Mean Patient Age: 59 years

Patient Populations:

  • Patients 18-75 years of age with an anterior MI treated by primary angioplasty
  • LVEF ≤40%

Exclusions:

  • Previous MI
  • Significant coronary narrowing in a nonculprit vessel
  • Pregnancy
  • Malignancy
  • Contraindication to magnetic resonance imaging

Primary Endpoints:

  • Change in LVEF
  • Change in LV volume

Secondary Endpoints:

Major adverse cardiac events defined as death, MI, stroke, or revascularization

Drug/Procedures Used:

Patients with acute MI and LVEF ≤40% were randomized to selected CD34+ CXCR4+ bone marrow cells (n = 80), unselected bone marrow cells (n = 80), or control (n = 40). Patients underwent cardiac magnetic resonance imaging at baseline and 6 months to assess LV function.

Principal Findings:

Overall, 200 patients were randomized. The median infusion of stem cells was 7 days.

In the selected stem cell group, LVEF increased from 35% to 38% (p = 0.04); in the unselected stem cell group, LVEF increased from 37% to 40% (p = 0.01); and in the control group, LVEF remained the same (39% at baseline and 39% follow-up, p = 0.73). There was no difference in the change in LVEF between the selected group and control (p = 0.19), or between the unselected group and control (p = 0.17). Among patients with a baseline LVEF <37%, LVEF increased in the selected stem cell group from 30% to 35% (p = 0.01), and from 31% to 36% in the unselected stem cell group (p = 0.007).

During follow-up, for selected versus unselected versus control, adverse events were similar: death (1.3% vs. 1.3% vs. 2.5%, p = 0.92), MI (5.0% vs. 1.3% vs. 5.0%, p = 0.61), and revascularization (15.0% vs. 16.2% vs. 17.5%, p = 0.87). There were no strokes in any group.

Interpretation:

Among patients with anterior MI and LV dysfunction, both selected and unselected bone marrow–derived stem cells resulted in an increase in LVEF at 6 months. This did not translate into a difference in LVEF at follow-up between the stem cell groups and control. This treatment effect was more pronounced among patients with more severe baseline LV dysfunction. Importantly, the use of stem cells appeared to be safe. This preliminary study should be followed by a larger clinical trial to examine the efficacy and safety of this therapy.

References:

Tendera M, Wojakowski W, Ruzyłło W, et al. Intracoronary infusion of bone marrow-derived selected CD34+CXCR4+ cells and non-selected mononuclear cells in patients with acute STEMI and reduced left ventricular ejection fraction: results of randomized, multicentre Myocardial Regeneration by Intracoronary Infusion of Selected Population of Stem Cells in Acute Myocardial Infarction (REGENT) Trial. Eur Heart J. 2009 Jun;30(11):1313-21.

Myocardial Regeneration by Intracoronary Infusion of Selected Population of Stem Cells in Acute Myocardial Infarction (REGENT) Randomized Multicenter Trial. Presented by Dr. Michal Tendera at the European Society of Cardiology Congress, Munich, Germany, August/September 2008.


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