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Stem cell therapy for heart disease.

ABSTRACT: Coronary artery disease is the leading cause of death in Americans. After myocardial infarction, significant ventricular damage persists despite timely reperfusion and pharmacological management. Treatment is limited, as current modalities do not cure this damage. In the past decade, stem cell therapy has emerged as a promising therapeutic solution to restore myocardial function. Clinical trials have demonstrated safety and beneficial effects in patients suffering from acute myocardial infarction, heart failure, and dilated cardiomyopathy. These benefits include improved ventricular function, increased ejection fraction, and decreased infarct size. Mechanisms of therapy are still not clearly understood. However, it is believed that paracrine factors, including stromal cell-derived factor-1, contribute significantly to stem cell benefits. The purpose of this article is to provide medical professionals with an overview on stem cell therapy for the heart and to discuss potential future directions.

SUBMITTER: Puliafico SB

PROVIDER: S-EPMC3785654 | biostudies-other | 2013 Oct

REPOSITORIES: biostudies-other

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Stem cell therapy for heart disease.

Puliafico Shannon B SB Penn Marc S MS Silver Kevin H KH

Journal of general internal medicine 20130615 10

Coronary artery disease is the leading cause of death in Americans. After myocardial infarction, significant ventricular damage persists despite timely reperfusion and pharmacological management. Treatment is limited, as current modalities do not cure this damage. In the past decade, stem cell therapy has emerged as a promising therapeutic solution to restore myocardial function. Clinical trials have demonstrated safety and beneficial effects in patients suffering from acute myocardial infarctio ...[more]

PMID: 23771782

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Project description:In the absence of effective endogenous repair mechanisms after cardiac injury, cell-based therapies have rapidly emerged as a potential novel therapeutic approach in ischaemic heart disease. After the initial characterization of putative endothelial progenitor cells and their potential to promote cardiac neovascularization and to attenuate ischaemic injury, a decade of intense research has examined several novel approaches to promote cardiac repair in adult life. A variety of adult stem and progenitor cells from different sources have been examined for their potential to promote cardiac repair and regeneration. Although early, small-scale clinical studies underscored the potential effects of cell-based therapy largely by using bone marrow (BM)-derived cells, subsequent randomized-controlled trials have revealed mixed results that might relate, at least in part, to differences in study design and techniques, e.g. differences in patient population, cell sources and preparation, and endpoint selection. Recent meta-analyses have supported the notion that administration of BM-derived cells may improve cardiac function on top of standard therapy. At this stage, further optimization of cell-based therapy is urgently needed, and finally, large-scale clinical trials are required to eventually proof its clinical efficacy with respect to outcomes, i.e. morbidity and mortality. Despite all promises, pending uncertainties and practical limitations attenuate the therapeutic use of stem/progenitor cells for ischaemic heart disease. To advance the field forward, several important aspects need to be addressed in carefully designed studies: comparative studies may allow to discriminate superior cell populations, timing, dosing, priming of cells, and delivery mode for different applications. In order to predict benefit, influencing factors need to be identified with the aim to focus resources and efforts. Local retention and fate of cells in the therapeutic target zone must be improved. Further understanding of regenerative mechanisms will enable optimization at all levels. In this context, cell priming, bionanotechnology, and tissue engineering are emerging tools and may merge into a combined biological approach of ischaemic tissue repair.

Project description:Objective: It is important to register clinical trials before their implementation. There is a lack of study to evaluate registered clinical trials of stem cell therapy for heart diseases. Our study used the registration information at ClinicalTrials.gov to provide an overview of the registered trials investigating stem cell therapy for heart diseases. Methods: We searched ClinicalTrials.gov from inception to October 1, 2020 to identify clinical trials evaluating stem cell therapy for heart diseases. These trials were included in a cross-sectional survey and descriptive analysis. The outcomes included start date, completion date, location, status, study results, funding, phase, study design, conditions, interventions, sex, age, and sample size of those trials, as well as conditions, efficacy, safety and samples of the publications. SPSS 24.0 software was used for the statistical analysis. Results: A total of 241 trials were included. The registration applications for most trials originated from the United States, and the research start date ranged from 2001 to 2025. More than half of the trials have been completed, but few trials have published results (15.62%). The funding source for 81.12% of trials was recorded as "other" because the specific funding source was not indicated. There were 226 (93.78%) interventional studies and 15 (6.22%) observational studies; among all 241 studies, only 2.90% were phase 4 trials. Most interventional studies used randomized allocation, parallel assignment, and blinding. Of the observational studies, 6 were cohort studies (40.00%) and 73.33% were prospective. The most common disease was coronary artery disease (57.68%) and 98.34% included both male and female participants. The sample size included fewer than 50 patients in 58.51% of trials, and only 18 trials (7.47%) lasted more than 121 months. The registered details were illogical for nine trials (3.8%) that included 0 subjects and two trials (0.8%) that had a duration of 0 months (0.8%). In term of publications of the trials, most of the publications of the trials showed efficacy and safety in stem cell therapy for heart disease. Conclusion: The clinical trials investigating stem cell therapy for heart diseases registered at ClinicalTrials.gov are mostly interventional studies, and only a few are phase 4 trials. Most trials have a small sample size, and few have a duration of more than 121 months. Most of the completed trials did not publish their results, and some of the registration information was incomplete and illogical.

Project description:Pathogenic causes underlying nonischemic cardiomyopathies are increasingly being resolved, yet repair therapies for these commonly heritable forms of heart failure are lacking. A case in point is human dilated cardiomyopathy 10 (CMD10; Online Mendelian Inheritance in Man #608569), a progressive organ dysfunction syndrome refractory to conventional therapies and linked to mutations in cardiac ATP-sensitive K(+) (K(ATP)) channel subunits. Embryonic stem cell therapy demonstrates benefit in ischemic heart disease, but the reparative capacity of this allogeneic regenerative cell source has not been tested in inherited cardiomyopathy. Here, in a Kir6.2-knockout model lacking functional K(ATP) channels, we recapitulated under the imposed stress of pressure overload the gene-environment substrate of CMD10. Salient features of the human malignant heart failure phenotype were reproduced, including compromised contractility, ventricular dilatation, and poor survival. Embryonic stem cells were delivered through the epicardial route into the left ventricular wall of cardiomyopathic stressed Kir6.2-null mutants. At 1 month of therapy, transplantation of 200,000 cells per heart achieved teratoma-free reversal of systolic dysfunction and electrical synchronization and halted maladaptive remodeling, thereby preventing end-stage organ failure. Tracked using the lacZ reporter transgene, stem cells engrafted into host heart. Beyond formation of cardiac tissue positive for Kir6.2, transplantation induced cell cycle activation and halved fibrotic zones, normalizing sarcomeric and gap junction organization within remuscularized hearts. Improved systemic function induced by stem cell therapy translated into increased stamina, absence of anasarca, and benefit to overall survivorship. Embryonic stem cells thus achieve functional repair in nonischemic genetic cardiomyopathy, expanding indications to the therapy of heritable heart failure. Disclosure of potential conflicts of interest is found at the end of this article.

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Stem cell therapy for heart disease.

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Stem cell therapy for heart disease.

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