Trial DesignRationale and Design of the SENECA (StEm cell iNjECtion in cAncer survivors) Trial☆
Section snippets
Study design
SENECA is a phase I, randomized, double-blind, placebo-controlled study to evaluate the safety and feasibility of delivering allo-MSCs by the transendocardial route in subjects with LV dysfunction secondary to AIC (clinicaltrials.gov Identifier: NCT02509156). This first-in-human trial, funded by the National Heart, Lung, and Blood Institute (NHLBI) and sponsored by the Cardiovascular Cell Therapy Research Network (CCTRN), will also collect preliminary evidence for the therapeutic efficacy of
Discussion
SENECA is the first clinical trial to utilize direct cardiac injection of cells for the treatment of AIC – an incurable and often fatal syndrome that disproportionately affects women and young adults, and for which no effective treatment currently exists.5., 7. This first-in-human study has the potential to herald a novel approach to the management of AIC.
Despite attempts at improving therapy, the prognosis of AIC is grim, worse than that of ischemic or idiopathic cardiomyopathy.5., 7.
Sources of Funding
This work is supported by National Institutes of Health, Bethesda, MD: 5 UM1 HL087318.
Disclosures
All investigators received funding from the NIH National Heart, Lung, and Blood Institute (NHLBI) for conduct of the Cardiovascular Cell Therapy Research Network (CCTRN). Additional disclosures: Hare has a relationship with Vestion Inc that includes equity, board membership, and consulting.
Acknowledgments
We thank the NHLBI-sponsored Protocol Review Committee and Gene and Cell Therapy DSMB for helpful guidance. Dr. Ebert is a staff member of the NHLBI, the source of funding for the SENECA Trial. The views expressed in this article are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute, National Institutes of Health, or the United States Department of Health and Human Services.
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Allogeneic Mesenchymal Cell Therapy in Anthracycline-Induced Cardiomyopathy Heart Failure Patients: The CCTRN SENECA Trial
2020, JACC: CardioOncologyCitation Excerpt :All subjects completed the following assessments: cardiac magnetic resonance imaging (CMR), 6-min walk test (6MWT), Minnesota Living with Heart Failure Questionnaire (MLHFQ), and a comprehensive laboratory panel that included N-terminal pro-brain natriuretic peptide (NT-proBNP). The methods for manufacturing the study product (allo-MSCs), as well as the strategy for targeting the transendocardial injections of study product, have been published elsewhere (21). Briefly, allo-MSCs were manufactured and released by the Center for Cell and Gene Therapy at the Baylor College of Medicine (Houston, Texas).
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RCT# NCT02509156.