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Multicenter randomized trial of cell therapy in cardiopathies - MiHeart Study
Bernardo R Tura1, Helena F Martino, Luis H Gowdak
1Instituto Nacional de Cardiologia Laranjeiras, Rio de Janeiro, Brazil. tura@centroin.com.br
Insights
This study investigates autologous bone marrow cell therapy for heart conditions. The research aims to improve ejection fraction in patients with various cardiomyopathies, offering new hope for cardiovascular disease treatment.
Area of Science:
- Regenerative Medicine
- Cardiology
- Clinical Trials
Background:
- Cardiovascular diseases represent a leading global cause of mortality.
- Existing treatments are insufficient, necessitating novel therapeutic approaches.
- Cell therapy shows promise for cardiac conditions, with emerging clinical evidence.
Purpose of the Study:
- To evaluate the efficacy of autologous bone marrow-derived mononuclear cell therapy.
- To assess treatment effects across four distinct cardiopathies: ischemic heart disease (acute and chronic), Chagasic cardiomyopathy, and dilated cardiomyopathy.
- To determine if cell therapy can improve left ventricular ejection fraction compared to placebo.
Main Methods:
- Multicenter, randomized, double-blind, placebo-controlled clinical trials.
- Enrollment of 300 patients per trial, receiving optimized standard care plus either autologous bone marrow cells or placebo.
- Intramyocardial or intracoronary cell delivery, with ejection fraction measured at 6 and 12 months post-intervention.
Main Results:
- The primary endpoint is the change in ejection fraction at 6 and 12 months.
- The main hypothesis predicts a 5% absolute increase in left ventricular ejection fraction in the cell therapy group versus placebo at 6 months.
- Detailed results on ejection fraction changes will be reported upon trial completion.
Conclusions:
- Previous Phase I trials suggest potential but yield conflicting results.
- Larger, well-controlled trials are essential to confirm the efficacy of cell therapies in various cardiomyopathies.
- This study's findings will contribute crucial data on the effectiveness of autologous bone marrow cell therapy for heart disease.
Background:
Cardiovascular diseases are the major cause of death in the world. Current treatments have not been able to reverse this scenario, creating the need for the development of new therapies. Cell therapies have emerged as an alternative for cardiac diseases of distinct causes in experimental animal studies and more recently in clinical trials.
Method/Design:
We have designed clinical trials to test for the efficacy of autologous bone marrow derived mononuclear cell therapies in four different cardiopathies: acute and chronic ischemic heart disease, and Chagasic and dilated cardiomyopathy. All trials are multicenter, randomized, double-blind and placebo controlled. In each trial 300 patients will be enrolled and receive optimized therapy for their specific condition. Additionally, half of the patients will receive the autologous bone marrow cells while the other half will receive placebo (saline with 5% autologous serum). For each trial there are specific inclusion and exclusion criteria and the method for cell delivery is intramyocardial for the chronic ischemic heart disease and intracoronary for all others. Primary endpoint for all studies will be the difference in ejection fraction (determined by Simpson's rule) six and twelve months after intervention in relation to the basal ejection fraction. The main hypothesis of this study is that the patients who receive the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean increase of 5% in absolute left ventricular ejection fraction in comparison with the control group.
Discussion:
Many phase I clinical trials using cell therapy for cardiac diseases have already been performed. The few randomized studies have yielded conflicting results, rendering necessary larger well controlled trials to test for efficacy of cell therapies in cardiopathies. The trials registration numbers at the NIH registry are the following: Chagasic cardiomyopathy (NCT00349271), dilated cardiomyopathy (NCT00333827), acute myocardial infarction (NCT00350766) and Chronic Ischemic Heart Disease (NCT00362388).
