Allogeneic Mesenchymal Cell Therapy in Anthracycline-Induced Cardiomyopathy Heart Failure Patients

Bolli, Roberto; Perin, Emerson C.; Willerson, James T.; Yang, Phillip C.; Traverse, Jay H.; Henry, Timothy D.; Pepine, Carl J.; Mitrani, Raul D.; Hare, Joshua M.; Murphy, Michael P.; March, Keith L.; Ikram, Sohail; Lee, David P.; Durand, Jean-Bernard; Miller, Kathy D.; Lima, João A.C.; Ostovaneh, Mohammad Reza; Ambale‐Venkatesh, Bharath; Gee, Adrian P.; Richman, Sara; Taylor, Doris A.; Sayre, Shelly L.; Bettencourt, Judy; Vojvodic, Rachel W.; Cohen, Mark H.; Simpson, Lara M.; Lai, Dejian; Aguilar, David; Loghin, Catalin; Moyé, Lem; Ebert, Ray F.; Davis, Barry R.; Simari, Robert D.

doi:10.1016/j.jaccao.2020.09.001

Cited by 33 publications

(35 citation statements)

References 32 publications

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“…Similarly, in a more recent dose-comparison study with allogeneic MSC in patients with ischemic cardiomyopathy (the TRIDENT study), no serious adverse events were found, and the highest dose was reported to have a beneficial effect [ 26 ]. Moreover, a recent trial involving patients with anthracycline-induced cardiomyopathy heart failure (CCTRN SENECA Trial) also revealed an acceptable safety profile of MSCs [ 27 ].…”

Section: Discussionmentioning

confidence: 99%

Preclinical Evaluation of the Safety and Immunological Action of Allogeneic ADSC-Collagen Scaffolds in the Treatment of Chronic Ischemic Cardiomyopathy

Cerio

Perez-Estenaga²,

Inogés

et al. 2021

Pharmaceutics

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The use of allogeneic adipose-derived mesenchymal stromal cells (alloADSCs) represents an attractive approach for treating myocardial infarction (MI). Furthermore, adding a natural support improves alloADSCs engraftment and survival in heart tissues, leading to a greater therapeutic effect. We aimed to examine the safety and immunological reaction induced by epicardial implantation of a clinical-grade collagen scaffold (CS) seeded with alloADSCs for its future application in humans. Thus, cellularized scaffolds were myocardially or subcutaneously implanted in immunosuppressed rodent models. The toxicological parameters were not significantly altered, and tumor formation was not found over the short or long term. Furthermore, biodistribution analyses in the infarcted immunocompetent rats displayed cell engraftment in the myocardium but no migration to other organs. The immunogenicity of alloADSC-CS was also evaluated in a preclinical porcine model of chronic MI; no significant humoral or cellular alloreactive responses were found. Moreover, CS cellularized with human ADSCs cocultured with human allogeneic immune cells produced no alloreactive response. Interestingly, alloADSC-CS significantly inhibited lymphocyte responses, confirming its immunomodulatory action. Thus, alloADSC-CS is likely safe and does not elicit any alloreactive immunological response in the host. Moreover, it exerts an immunomodulatory action, which supports its translation to a clinical setting.

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Section: Discussionmentioning

confidence: 99%

Preclinical Evaluation of the Safety and Immunological Action of Allogeneic ADSC-Collagen Scaffolds in the Treatment of Chronic Ischemic Cardiomyopathy

Cerio

Perez-Estenaga²,

Inogés

et al. 2021

Pharmaceutics

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“…Based on publicly available FDA reviews of women enrolled in late-phase pivotal-trials supporting 36 drug approvals from 2005 to 2015, women were well represented in trials of drugs for hypertension and atrial fibrillation and over-represented for pulmonary arterial hypertension. A recent phase 1 study of allogeneic MSCs for anthracycline-induced cardiomyopathy (SENECA; NCT02509156) also had a high representation (68%) of women [ 33 ]. Representation of women fell below a PPR of 0.8 for trials in heart failure, coronary artery disease, and acute coronary syndrome, with minimal sex differences in drug efficacy and observed safety profiles [ 34 ].…”

Section: Discussionmentioning

confidence: 99%

Demographic representation in clinical trials for cell-based therapy

Saltzman

Jayaweera

Caceres

et al. 2021

Contemporary Clinical Trials Communications

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“…The approach of the SENECA study represents the first clinical trial for treating AIC through direct cardiac injection of cells. Preliminary results and further investigations have been published [ 75 ] [ 76 ]. The researchers involved in this trial concluded that transendocardial cell administration appears safe and feasible, although the phase I study was small and not powered or designed to assess efficacy; larger phase II and III trials aimed at assessing efficacy are needed.…”

Section: Cardiovascular Diseasesmentioning

confidence: 99%

Clinical Trials Based on Mesenchymal Stromal Cells are Exponentially Increasing: Where are We in Recent Years?

Galderisi

Peluso²,

Bernardo

2021

Stem Cell Rev and Rep

119

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Mesenchymal stromal cells (MSCs), present in the stromal component of several tissues, include multipotent stem cells, progenitors, and differentiated cells. MSCs have quickly attracted considerable attention in the clinical field for their regenerative properties and their ability to promote tissue homeostasis following injury. In recent years, MSCs mainly isolated from bone marrow, adipose tissue, and umbilical cord—have been utilized in hundreds of clinical trials for the treatment of various diseases. However, in addition to some successes, MSC-based therapies have experienced several failures. The number of new trials with MSCs is exponentially growing; still, complete results are only available for a limited number of trials. This dearth does not help prevent potentially inefficacious and unnecessary clinical trials. Results from unsuccessful studies may be useful in planning new therapeutic approaches to improve clinical outcomes. In order to bolster critical analysis of trial results, we reviewed the state of art of MSC clinical trials that have been published in the last six years. Most of the 416 published trials evaluated MSCs’ effectiveness in treating cardiovascular diseases, GvHD, and brain and neurological disorders, although some trials sought to treat immune system diseases and wounds and to restore tissue. We also report some unorthodox clinical trials that include unusual studies. Graphical abstract

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Allogeneic Mesenchymal Cell Therapy in Anthracycline-Induced Cardiomyopathy Heart Failure Patients

Cited by 33 publications

References 32 publications

Preclinical Evaluation of the Safety and Immunological Action of Allogeneic ADSC-Collagen Scaffolds in the Treatment of Chronic Ischemic Cardiomyopathy

Preclinical Evaluation of the Safety and Immunological Action of Allogeneic ADSC-Collagen Scaffolds in the Treatment of Chronic Ischemic Cardiomyopathy

Demographic representation in clinical trials for cell-based therapy

Clinical Trials Based on Mesenchymal Stromal Cells are Exponentially Increasing: Where are We in Recent Years?

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