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      Transplantation of mesenchymal stem cells for prevention of acute myocardial infarction induced heart failure: study protocol of a phase III randomized clinical trial (Prevent-TAHA8)

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          Abstract

          Background

          Results from recent clinical trials on bone marrow mononuclear cell (BM-MNC) transplantation show that this intervention can help reduce the incidence of heart failure (HF) after acute myocardial infarction (AMI). However, no study has evaluated the effect of the transplantation of mesenchymal stem cells (MSCs) on a clinical endpoint such as HF.

          Methods

          This single-blinded, randomized, multicenter trial aims to establish whether the intracoronary infusion of umbilical cord-derived Wharton’s jelly MSCs (WJ-MSCs) helps prevent HF development after AMI. The study will enroll 390 patients 3 to 7 days following AMI. Only patients aged below 65 years with impaired LV function (LVEF < 40%) will be included. They will be randomized (2:1 ratio) to either receive standard care or a single intracoronary infusion of 10 7 WJ-MSCs. The primary outcome of this study is the assessment of HF development during long-term follow-up (3 years).

          Discussion

          Data will be collected until Nov 2024. Thereafter, the analysis will be conducted. Results are expected to be ready by Dec 2024. We will prepare and submit the related manuscript following the CONSORT guidelines. This study will help determine whether or not the infusion of intracoronary WJ-MSCs in patients with AMI will reduce the incidence of AMI-induced HF.

          Trial registration

          ClinicalTrials.gov NCT05043610, Registered on 14 September 2021 - retrospectively registered.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s13063-022-06594-1.

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          Comparison of allogeneic vs autologous bone marrow–derived mesenchymal stem cells delivered by transendocardial injection in patients with ischemic cardiomyopathy: the POSEIDON randomized trial.

          Joshua Hare, Joel Fishman, Gary Gerstenblith … (2012)
          Mesenchymal stem cells (MSCs) are under evaluation as a therapy for ischemic cardiomyopathy (ICM). Both autologous and allogeneic MSC therapies are possible; however, their safety and efficacy have not been compared. To test whether allogeneic MSCs are as safe and effective as autologous MSCs in patients with left ventricular (LV) dysfunction due to ICM. A phase 1/2 randomized comparison (POSEIDON study) in a US tertiary-care referral hospital of allogeneic and autologous MSCs in 30 patients with LV dysfunction due to ICM between April 2, 2010, and September 14, 2011, with 13-month follow-up. Twenty million, 100 million, or 200 million cells (5 patients in each cell type per dose level) were delivered by transendocardial stem cell injection into 10 LV sites. Thirty-day postcatheterization incidence of predefined treatment-emergent serious adverse events (SAEs). Efficacy assessments included 6-minute walk test, exercise peak VO2, Minnesota Living with Heart Failure Questionnaire (MLHFQ), New York Heart Association class, LV volumes, ejection fraction (EF), early enhancement defect (EED; infarct size), and sphericity index. Within 30 days, 1 patient in each group (treatment-emergent SAE rate, 6.7%) was hospitalized for heart failure, less than the prespecified stopping event rate of 25%. The 1-year incidence of SAEs was 33.3% (n = 5) in the allogeneic group and 53.3% (n = 8) in the autologous group (P = .46). At 1 year, there were no ventricular arrhythmia SAEs observed among allogeneic recipients compared with 4 patients (26.7%) in the autologous group (P = .10). Relative to baseline, autologous but not allogeneic MSC therapy was associated with an improvement in the 6-minute walk test and the MLHFQ score, but neither improved exercise VO2 max. Allogeneic and autologous MSCs reduced mean EED by −33.21% (95% CI, −43.61% to −22.81%; P < .001) and sphericity index but did not increase EF. Allogeneic MSCs reduced LV end-diastolic volumes. Low-dose concentration MSCs (20 million cells) produced greatest reductions in LV volumes and increased EF. Allogeneic MSCs did not stimulate significant donor-specific alloimmune reactions. In this early-stage study of patients with ICM, transendocardial injection of allogeneic and autologous MSCs without a placebo control were both associated with low rates of treatment-emergent SAEs, including immunologic reactions. In aggregate, MSC injection favorably affected patient functional capacity, quality of life, and ventricular remodeling. clinicaltrials.gov Identifier: NCT01087996.
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            Mesenchymal stem cells: biology, pathophysiology, translational findings, and therapeutic implications for cardiac disease.

            Adam Williams, Joshua Hare (2011)
            Mesenchymal stem cells (MSCs) are a prototypical adult stem cell with capacity for self-renewal and differentiation with a broad tissue distribution. Initially described in bone marrow, MSCs have the capacity to differentiate into mesoderm- and nonmesoderm-derived tissues. The endogenous role for MSCs is maintenance of stem cell niches (classically the hematopoietic), and as such, MSCs participate in organ homeostasis, wound healing, and successful aging. From a therapeutic perspective, and facilitated by the ease of preparation and immunologic privilege, MSCs are emerging as an extremely promising therapeutic agent for tissue regeneration. Studies in animal models of myocardial infarction have demonstrated the ability of transplanted MSCs to engraft and differentiate into cardiomyocytes and vasculature cells, recruit endogenous cardiac stem cells, and secrete a wide array of paracrine factors. Together, these properties can be harnessed to both prevent and reverse remodeling in the ischemically injured ventricle. In proof-of-concept and phase I clinical trials, MSC therapy improved left ventricular function, induced reverse remodeling, and decreased scar size. This article reviews the current understanding of MSC biology, mechanism of action in cardiac repair, translational findings, and early clinical trial data of MSC therapy for cardiac disease.
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              Cell therapy for heart failure: a comprehensive overview of experimental and clinical studies, current challenges, and future directions.

              Santosh K Sanganalmath, Roberto Bolli (2013)
              Despite significant therapeutic advances, the prognosis of patients with heart failure (HF) remains poor, and current therapeutic approaches are palliative in the sense that they do not address the underlying problem of the loss of cardiac tissue. Stem cell-based therapies have the potential to fundamentally transform the treatment of HF by achieving what would have been unthinkable only a few years ago-myocardial regeneration. For the first time since cardiac transplantation, a therapy is being developed to eliminate the underlying cause of HF, not just to achieve damage control. Since the initial report of cell therapy (skeletal myoblasts) in HF in 1998, research has proceeded at lightning speed, and numerous preclinical and clinical studies have been performed that support the ability of various stem cell populations to improve cardiac function and reduce infarct size in both ischemic and nonischemic cardiomyopathy. Nevertheless, we are still at the dawn of this therapeutic revolution. Many important issues (eg, mechanism(s) of action of stem cells, long-term engraftment, optimal cell type(s), and dose, route, and frequency of cell administration) remain to be resolved, and no cell therapy has been conclusively shown to be effective. The purpose of this article is to critically review the large body of work performed with respect to the use of stem/progenitor cells in HF, both at the experimental and clinical levels, and to discuss current controversies, unresolved issues, challenges, and future directions. The review focuses specifically on chronic HF; other settings (eg, acute myocardial infarction, refractory angina) are not discussed.
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                Author and article information

                Contributors
                Armin Attar:
                ORCID: http://orcid.org/0000-0002-4133-4870
                attarar@sums.ac.ir
                Journal
                Journal ID (nlm-ta): Trials
                Journal ID (iso-abbrev): Trials
                Title: Trials
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1745-6215
                Publication date (Electronic): 4 August 2022
                Publication date PMC-release: 4 August 2022
                Publication date Collection: 2022
                Volume: 23
                Electronic Location Identifier: 632
                Affiliations
                [1 ]GRID grid.412571.4, ISNI 0000 0000 8819 4698, Department of Cardiovascular Medicine, TAHA Clinical Trial Group, , Shiraz University of Medical Sciences, ; Zand Street, Shiraz, 71344-1864 Iran
                [2 ]GRID grid.412571.4, ISNI 0000 0000 8819 4698, Hematology Research Center, , Shiraz University of Medical Sciences, ; Shiraz, Iran
                [3 ]GRID grid.412571.4, ISNI 0000 0000 8819 4698, Department of Pathology, , Shiraz University of Medical Sciences, ; Shiraz, Iran
                [4 ]GRID grid.412571.4, ISNI 0000 0000 8819 4698, Student Research Committee, , Shiraz University of Medical Sciences, ; Shiraz, Iran
                [5 ]GRID grid.419336.a, ISNI 0000 0004 0612 4397, Department of Regenerative Medicine, Cell Science Research Center, , Royan Institute for Stem Cell Biology and Technology, ACECR, ; Tehran, Iran
                [6 ]GRID grid.412571.4, ISNI 0000 0000 8819 4698, Transplant Research Center, , Shiraz University of Medical Sciences, ; Shiraz, Iran
                [7 ]GRID grid.412571.4, ISNI 0000 0000 8819 4698, Clinical Microbiology Research Center, Nemazee Hospital, , Shiraz University of Medical Sciences, ; Shiraz, Iran
                Author information
                http://orcid.org/0000-0002-4133-4870
                Article
                Publisher ID: 6594
                DOI: 10.1186/s13063-022-06594-1
                PMC ID: 9351242
                PubMed ID: 35927674
                SO-VID: bd2b5131-4405-4257-b2bc-579b5869712a
                Copyright © © The Author(s) 2022
                License:

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                Date received : 25 October 2021
                Date accepted : 25 July 2022
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100004320, Shiraz University of Medical Sciences;
                Award ID: SG-98-5, SG-98-94, and SG-96-86
                Award Recipient :
                Categories
                Subject: Study Protocol
                Custom metadata
                issue-copyright-statement © The Author(s) 2022

                ScienceOpen disciplines: Medicine
                Keywords: regenerative medicine,cell therapy,myocardial infarction,mesenchymal stem cells,intracoronary injection,acute myocardial infarction
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: regenerative medicine, cell therapy, myocardial infarction, mesenchymal stem cells, intracoronary injection, acute myocardial infarction

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