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Published on: September 3, 2020
Results of intracoronary stem cell therapy after acute myocardial infarction
Jochen Wöhrle1, Nico Merkle, Volker Mailänder
1University of Ulm, Clinic for Internal Medicine II, Ulm, Germany. jochen.woehrle@uniklinik-ulm.de
Insights
Autologous bone-marrow cell (BMC) therapy did not improve left ventricular ejection fraction in patients with acute myocardial infarction. This randomized trial found no significant benefit of BMC therapy over placebo for cardiac function or infarct size.
Area of Science:
- Regenerative Medicine
- Cardiology
- Clinical Trials
Background:
- Acute myocardial infarction (AMI) remains a leading cause of mortality and morbidity.
- Cell-based therapies, including autologous bone-marrow cells (BMCs), are being investigated to improve outcomes after AMI.
- Assessing the efficacy of BMC therapy requires rigorous clinical trials to establish its therapeutic value.
Purpose of the Study:
- To evaluate the effect of intracoronary autologous bone-marrow cell (BMC) therapy on left ventricular (LV) function and infarct size in patients with acute myocardial infarction (AMI).
- To conduct a double-blind, randomized, placebo-controlled trial to rigorously assess the efficacy of BMC therapy.
- To determine if BMC therapy improves LV ejection fraction, LV volumes, and infarct size compared to placebo.
Main Methods:
- A double-blind, randomized, placebo-controlled trial involving 42 patients with AMI who received either intracoronary BMC or placebo therapy.
- Patients were stratified by age, AMI localization, and LV function, with randomization in a 2:1 ratio.
- Cardiac magnetic resonance imaging (CMR) was used to assess LV ejection fraction, LV volumes, and infarct size at baseline and at 1, 3, and 6 months post-therapy.
Main Results:
- The primary end point, change in LV ejection fraction from baseline to 6 months, was not significantly different between the BMC group (-0.9 +/- 5.5%) and the placebo group (5.7 +/- 8.4%).
- No significant differences were observed in secondary end points, including changes in LV end-diastolic volume index, LV end-systolic volume index, or infarct size between the two groups.
- Despite administration of a mean of 381 x 10^6 mononuclear BMCs, the study did not demonstrate a therapeutic benefit of BMC therapy over placebo.
Conclusions:
- Intracoronary autologous bone-marrow cell (BMC) therapy did not show a significant positive effect on left ventricular ejection fraction in patients with acute myocardial infarction (AMI) within 6 months.
- The study found no evidence of benefit for BMC therapy compared to placebo regarding improvements in LV volume indexes or infarct size.
- These findings suggest that, in this rigorously controlled trial, BMC therapy is not effective for improving cardiac function or reducing infarct size after AMI.
Abstract:
To assess the effect of autologous bone-marrow cell (BMC) therapy in patients with acute myocardial infarction in a rigorous double-blind, randomized, placebo-controlled trial. Patients with reperfusion >6 hours after symptom onset were randomly assigned in a 2:1 ratio to receive intracoronary BMC or placebo therapy 5 to 7 days after symptom onset. The patients were stratified according to age, acute myocardial infarction localization, and left ventricular (LV) function. Rigorous double-blinding was ensured using autologous erythrocytes for the placebo preparation that was visually indistinguishable from the active treatment. Serial cardiac magnetic resonance imaging studies were performed before study therapy and after 1, 3, and 6 months. The primary end point was the difference in the LV ejection fraction from baseline to 6 months. The secondary end points included changes in the LV end-diastolic and end-systolic volume indexes and infarct size. A total of 42 patients were enrolled (29 in the BMC group and 13 in the placebo group) in the integrated pilot phase. A mean of 381 x 10(6) mononuclear BMCs were administered. The baseline clinical and cardiac magnetic resonance imaging parameters did not differ. Compared to baseline, the difference in LV ejection fraction for the placebo group versus BMC group was 1.7 +/- 6.4% versus -0.9 +/- 5.5% at 1 month, 3.1 +/- 6.0% versus 1.9 +/- 4.3% at 3 months, and 5.7 +/- 8.4% versus 1.8 +/- 5.3% at 6 months (primary end point; not significant). No difference was found in the secondary end points between the 2 groups, including changes in infarct size or LV end-diastolic and end-systolic volume indexes. In conclusion, in this rigorous double-blind, randomized, placebo-controlled trial, we did not observe an evidence for a positive effect for intracoronary BMC versus placebo therapy with respect to LV ejection fraction, LV volume indexes, or infarct size.
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