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Intracoronary stem cell transplant in ischemic heart disease: a meta-analysis of randomized trials
F Puppo1, V Fontana, A Monselise
1Department of Internal Medicine, University of Genoa, Genoa, Italy. magister1@mail.com.
Insights
Intracoronary stem cell transplantation significantly improves left ventricular ejection fraction (LVEF) in patients with ischemic heart disease. This therapy also reduces functional class severity, offering a manageable approach for future trials.
Area of Science:
- Cardiology
- Regenerative Medicine
- Clinical Trials
Background:
- Ischemic heart disease (IHD) is a major cause of death and disability worldwide.
- Left ventricular ejection fraction (LVEF) is a key indicator of cardiac function and prognosis.
- Current treatments for IHD have limitations, necessitating novel therapeutic strategies.
Purpose of the Study:
- To evaluate the efficacy of intracoronary stem cell transplantation on LVEF in patients with acute myocardial infarction, chronic ischemic heart disease, and severe ischemic heart failure.
- To compare outcomes based on stem cell type and dosage.
- To assess the impact on New York Heart Association (NYHA) functional class.
Main Methods:
- A meta-analysis of 82 randomized controlled trials (2002-2025) involving 5,781 patients.
- Analysis of covariance was used to calculate the mean difference in LVEF at 6 months post-transplantation.
- Heterogeneity and publication bias were assessed using standard statistical methods.
Main Results:
- Intracoronary stem cell therapy resulted in an overall LVEF increase of 3.3%, with greater improvements in chronic ischemic heart disease (8.2%) and ischemic heart failure (5.3%).
- A dose-response relationship was observed, with a 2% LVEF increase per 10^9 cells infused.
- Significant reduction in NYHA functional class was noted in ischemic heart failure patients post-transplantation.
Conclusions:
- Intracoronary stem cell transplantation is an effective therapy for improving LVEF in patients with acute and chronic ischemic heart disease.
- The procedure is associated with a significant decrease in functional class severity.
- The intracoronary route presents a manageable and simple option for future stem cell therapy trials in IHD.
Objective:
Ischemic heart disease is a leading cause of morbidity and mortality. In this study, we assessed the efficacy of intracoronary stem cell transplantation on left ventricular function (LVEF) in acute myocardial infarction, chronic ischemic heart disease, and severe ischemic heart failure. MATERIALS AND METHODS: We conducted a meta-analysis of randomized trials from 2002 to 2025. Mean difference in LVEF between treated and control patients at 6-months after infusion was calculated according to analysis of covariance. Heterogeneity among studies was assessed by the Cochrane's Q, Tau2, and I2 statistics. The primary outcome was the LVEF difference at follow-up. Secondary outcomes were comparisons among the type and number of transplanted stem cells.
Results:
The analysis included 82 randomized controlled trials totaling 5,781 patients (3,048 treated and 2,733 controls) affected by acute myocardial infarction (AMI, n. 70), chronic ischemic heart disease (CIHD, n. 5), and ischemic heart failure (IHF, n. 7). Stem cells were bone marrow, mesenchymal, peripheral blood, and cardiac stem cells in 58, 15, 6 and 3 studies, respectively. Median infused cells were 100 x 106. LVEF increased 3.3% overall and 8.2%, 5.3% and 2.7% in CIHD, IHF and AMI, respectively. LVEF increased 2% per each 109 cells. CIHD improved from mild (46%) to normal (54%) and IHF from severe (30%) to moderate (38%) functional class. Study heterogeneity decreased over publication year, and there is evidence for publication bias, although the Egger's test resulted in a non-significant result. Intracoronary stem cells induced a significant decrease in mean New York Heart Association (NYHA) functional class from baseline to 6 and 12 months after transplant (2.6, 1.8, and 1.9, respectively; t-test p = 0.002) in ischemic heart failure patients. CONCLUSIONS: Intracoronary stem cell transplantation improves LVEF in acute and chronic ischemic heart disease and is associated with a reduction of functional class severity. The intracoronary route may be taken into consideration in future trials of stem cell therapy for ischemic heart disease due to its relative manageability and simplicity.
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