Intramyocardial transplantation of mesenchymal stromal cells for chronic myocardial ischemia and impaired left ventricular function: Results of the MESAMI 1 pilot trial

Guijarro, Damien; Lebrin, Marine; Lairez, Olivier; Bourin, Philippe; Piriou, N.; Pozzo, Joffrey; Lande, Gilles; Berry, Matthieu; Tourneau, Thierry Le; Cussac, Daniel; Sensebé, Luc; Gross, Fabian; Lamirault, Guillaume; Huynh, Alexander; Manrique, Alain; Ruidavet, J B; Elbaz, M.; Trochu, Jean Noël; Parini, Angelo; Kramer, Sage P.; Galinier, Michel; Lemarchand, Patricia; Roncalli, Jérôme

doi:10.1016/j.ijcard.2016.02.016

Cited by 63 publications

(39 citation statements)

References 26 publications

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“…Of the 23 included studies, 11 evaluated AMI ( n = 509 patients) and 12 evaluated IHF ( n = 639 patients) (Table ). Of these studies, eight were RCTs that evaluated AMI ( n = 429 patients) and five were RCTs that evaluated IHF ( n = 472 patients) .…”

Section: Resultsmentioning

confidence: 99%

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Safety and Efficacy of Adult Stem Cell Therapy for Acute Myocardial Infarction and Ischemic Heart Failure (SafeCell Heart): A Systematic Review and Meta-Analysis

Lalu

Mazzarello

Zlepnig

et al. 2018

Stem Cells Translational Medicine

103

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Preclinical and clinical evidence suggests that mesenchymal stem cells (MSCs) may be beneficial in treating both acute myocardial infarction (AMI) and ischemic heart failure (IHF). However, the safety profile and efficacy of MSC therapy is not well‐known. We conducted a systematic review of clinical trials that evaluated the safety or efficacy of MSCs for AMI or IHF. Embase, PubMed/Medline, and Cochrane Central Register of Controlled Trials were searched from inception to September 27, 2017. Studies that examined the use of MSCs administered to adults with AMI or IHF were eligible. The Cochrane risk of bias tool was used to assess bias of included studies. The primary outcome was safety assessed by adverse events and the secondary outcome was efficacy which was assessed by mortality and left ventricular ejection fraction (LVEF). A total of 668 citations were reviewed and 23 studies met eligibility criteria. Of these, 11 studies evaluated AMI and 12 studies evaluated IHF. There was no association between MSCs and acute adverse events. There was a significant improvement in overall LVEF in patients who received MSCs (SMD 0.73, 95% CI 0.24–1.21). No significant difference in mortality was noted (Peto OR 0.68, 95% CI 0.38–1.22). Results from our systematic review suggest that MSC therapy for ischemic heart disease appears to be safe. There is a need for a well‐designed adequately powered randomized control trial (with rigorous adverse event reporting and evaluations of cardiac function) to further establish a clear risk‐benefit profile of MSCs. Stem Cells Translational Medicine 2018;7:857–866

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Section: Resultsmentioning

confidence: 99%

“…Secondary outcomes assessed included safety or efficacy . Of the IHF studies, four studies evaluated safety , four studies evaluated efficacy , and four studies evaluated both as the primary outcome. Secondary outcomes assessed included efficacy or both efficacy and safety .…”

Section: Resultsmentioning

confidence: 99%

Safety and Efficacy of Adult Stem Cell Therapy for Acute Myocardial Infarction and Ischemic Heart Failure (SafeCell Heart): A Systematic Review and Meta-Analysis

Lalu

Mazzarello

Zlepnig

et al. 2018

Stem Cells Translational Medicine

103

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“…They also suggested a possible correlation between cell dose and disease severity. Through a longer, 2-year follow-up, the phase 1 pilot study MESAMI revealed similar benefits from intramyocardial MSC injection in patients with chronic ischemic cardiomyopathy, albeit with a smaller sample size of 10 (58). …”

Section: Bone Marrow-derived Mesenchymal Stem Cellsmentioning

confidence: 96%

Cardiac Stem Cells for Myocardial Regeneration: They Are Not Alone

Leong

Ellison

et al. 2017

Front. Cardiovasc. Med.

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Heart failure is the number one killer worldwide with ~50% of patients dying within 5 years of prognosis. The discovery of stem cells, which are capable of repairing the damaged portion of the heart, has created a field of cardiac regenerative medicine, which explores various types of stem cells, either autologous or endogenous, in the hope of finding the “holy grail” stem cell candidate to slow down and reverse the disease progression. However, there are many challenges that need to be overcome in the search of such a cell candidate. The ideal cells have to survive the harsh infarcted environment, retain their phenotype upon administration, and engraft and be activated to initiate repair and regeneration in vivo. Early bench and bedside experiments mostly focused on bone marrow-derived cells; however, heart regeneration requires multiple coordinations and interactions between various cell types and the extracellular matrix to form new cardiomyocytes and vasculature. There is an observed trend that when more than one cell is coadministered and cotransplanted into infarcted animal models the degree of regeneration is enhanced, when compared to single-cell administration. This review focuses on stem cell candidates, which have also been tested in human trials, and summarizes findings that explore the interactions between various stem cells in heart regenerative therapy.

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“…Cellular therapy aimed at improving cardiac function and regenerating new myocardium, has been extensively investigated for cardiac repair 3 . Despite numerous preclinical and clinical studies 4–9 performed to assess the ability of various stem cell populations to improve cardiac function and reduce infarct size, many important issues remain unresolved, and no cell therapy to date has been demonstrated conclusively to be effective. There are significant limitations to cell therapy in terms of cell retention, survival of the engrafted cells, cell differentiation, and integration of transplanted cells with host tissue 10 .…”

Section: Introductionmentioning

confidence: 99%

Biomaterial-Free Three-Dimensional Bioprinting of Cardiac Tissue using Human Induced Pluripotent Stem Cell Derived Cardiomyocytes

Ong

Fukunishi

Zhang

et al. 2017

Sci Rep

204

169

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We have developed a novel method to deliver stem cells using 3D bioprinted cardiac patches, free of biomaterials. Human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs), fibroblasts (FB) and endothelial cells (EC) were aggregated to create mixed cell spheroids. Cardiac patches were created from spheroids (CM:FB:EC = 70:15:15, 70:0:30, 45:40:15) using a 3D bioprinter. Cardiac patches were analyzed with light and video microscopy, immunohistochemistry, immunofluorescence, cell viability assays and optical electrical mapping. Cardiac tissue patches of all cell ratios beat spontaneously after 3D bioprinting. Patches exhibited ventricular-like action potential waveforms and uniform electrical conduction throughout the patch. Conduction velocities were higher and action potential durations were significantly longer in patches containing a lower percentage of FBs. Immunohistochemistry revealed staining for CM, FB and EC markers, with rudimentary CD31+ blood vessel formation. Immunofluorescence revealed the presence of Cx43, the main cardiac gap junction protein, localized to cell-cell borders. In vivo implantation suggests vascularization of 3D bioprinted cardiac patches with engraftment into native rat myocardium. This constitutes a significant step towards a new generation of stem cell-based treatment for heart failure.

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Intramyocardial transplantation of mesenchymal stromal cells for chronic myocardial ischemia and impaired left ventricular function: Results of the MESAMI 1 pilot trial

Abstract: Unique identifier: NCT01076920.

Cited by 63 publications

References 26 publications

Safety and Efficacy of Adult Stem Cell Therapy for Acute Myocardial Infarction and Ischemic Heart Failure (SafeCell Heart): A Systematic Review and Meta-Analysis

Safety and Efficacy of Adult Stem Cell Therapy for Acute Myocardial Infarction and Ischemic Heart Failure (SafeCell Heart): A Systematic Review and Meta-Analysis

Cardiac Stem Cells for Myocardial Regeneration: They Are Not Alone

Biomaterial-Free Three-Dimensional Bioprinting of Cardiac Tissue using Human Induced Pluripotent Stem Cell Derived Cardiomyocytes

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