Rationale and Design of the SENECA (StEm cell iNjECtion in cAncer survivors) Trial
SENECA (StEm cell iNjECtion in cAncer survivors) is a phase I, randomized, double-blind, placebo-controlled study to evaluate the safety and feasibility of delivering allogeneic mesenchymal stromal cells (allo-MSCs) transendocardially in subjects with anthracycline-induced cardiomyopathy (AIC). AIC...
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| Published in | The American heart journal Vol. 201; pp. 54 - 62 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
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United States
Elsevier Inc
01.07.2018
Elsevier Limited |
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| Abstract | SENECA (StEm cell iNjECtion in cAncer survivors) is a phase I, randomized, double-blind, placebo-controlled study to evaluate the safety and feasibility of delivering allogeneic mesenchymal stromal cells (allo-MSCs) transendocardially in subjects with anthracycline-induced cardiomyopathy (AIC).
AIC is an incurable and often fatal syndrome, with a prognosis worse than that of ischemic or nonischemic cardiomyopathy. Recently, cell therapy with MSCs has emerged as a promising new approach to repair damaged myocardium.
The study population is 36 cancer survivors with a diagnosis of AIC, left ventricular (LV) ejection fraction ≤40%, and symptoms of heart failure (NYHA class II-III) on optimally-tolerated medical therapy. Subjects must be clinically free of cancer for at least two years with a ≤ 30% estimated five-year risk of recurrence. The first six subjects participated in an open-label, lead-in phase and received 100 million allo-MSCs; the remaining 30 will be randomized 1:1 to receive allo-MSCs or vehicle via 20 transendocardial injections. Efficacy measures (obtained at baseline, 6 months, and 12 months) include MRI evaluation of LV function, LV volumes, fibrosis, and scar burden; assessment of exercise tolerance (six-minute walk test) and quality of life (Minnesota Living with Heart Failure Questionnaire); clinical outcomes (MACE and cumulative days alive and out of hospital); and biomarkers of heart failure (NT-proBNP).
This is the first clinical trial using direct cardiac injection of cells for the treatment of AIC. If administration of allo-MSCs is found feasible and safe, SENECA will pave the way for larger phase II/III studies with therapeutic efficacy as the primary outcome. |
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| AbstractList | SENECA (StEm cell iNjECtion in cAncer survivors) is a phase I, randomized, double-blind, placebo-controlled study to evaluate the safety and feasibility of delivering allogeneic mesenchymal stromal cells (allo-MSCs) transendocardially in subjects with anthracycline-induced cardiomyopathy (AIC).
AIC is an incurable and often fatal syndrome, with a prognosis worse than that of ischemic or nonischemic cardiomyopathy. Recently, cell therapy with MSCs has emerged as a promising new approach to repair damaged myocardium.
The study population is 36 cancer survivors with a diagnosis of AIC, left ventricular (LV) ejection fraction ≤40%, and symptoms of heart failure (NYHA class II-III) on optimally-tolerated medical therapy. Subjects must be clinically free of cancer for at least two years with a ≤ 30% estimated five-year risk of recurrence. The first six subjects participated in an open-label, lead-in phase and received 100 million allo-MSCs; the remaining 30 will be randomized 1:1 to receive allo-MSCs or vehicle via 20 transendocardial injections. Efficacy measures (obtained at baseline, 6 months, and 12 months) include MRI evaluation of LV function, LV volumes, fibrosis, and scar burden; assessment of exercise tolerance (six-minute walk test) and quality of life (Minnesota Living with Heart Failure Questionnaire); clinical outcomes (MACE and cumulative days alive and out of hospital); and biomarkers of heart failure (NT-proBNP).
This is the first clinical trial using direct cardiac injection of cells for the treatment of AIC. If administration of allo-MSCs is found feasible and safe, SENECA will pave the way for larger phase II/III studies with therapeutic efficacy as the primary outcome. SENECA (StEm cell iNjECtion in cAncer survivors) is a phase I, randomized, double-blind, placebo-controlled study to evaluate the safety and feasibility of delivering allogeneic mesenchymal stromal cells (allo-MSCs) transendocardially in subjects with anthracycline-induced cardiomyopathy (AIC).OBJECTIVESSENECA (StEm cell iNjECtion in cAncer survivors) is a phase I, randomized, double-blind, placebo-controlled study to evaluate the safety and feasibility of delivering allogeneic mesenchymal stromal cells (allo-MSCs) transendocardially in subjects with anthracycline-induced cardiomyopathy (AIC).AIC is an incurable and often fatal syndrome, with a prognosis worse than that of ischemic or nonischemic cardiomyopathy. Recently, cell therapy with MSCs has emerged as a promising new approach to repair damaged myocardium.BACKGROUNDAIC is an incurable and often fatal syndrome, with a prognosis worse than that of ischemic or nonischemic cardiomyopathy. Recently, cell therapy with MSCs has emerged as a promising new approach to repair damaged myocardium.The study population is 36 cancer survivors with a diagnosis of AIC, left ventricular (LV) ejection fraction ≤40%, and symptoms of heart failure (NYHA class II-III) on optimally-tolerated medical therapy. Subjects must be clinically free of cancer for at least two years with a ≤ 30% estimated five-year risk of recurrence. The first six subjects participated in an open-label, lead-in phase and received 100 million allo-MSCs; the remaining 30 will be randomized 1:1 to receive allo-MSCs or vehicle via 20 transendocardial injections. Efficacy measures (obtained at baseline, 6 months, and 12 months) include MRI evaluation of LV function, LV volumes, fibrosis, and scar burden; assessment of exercise tolerance (six-minute walk test) and quality of life (Minnesota Living with Heart Failure Questionnaire); clinical outcomes (MACE and cumulative days alive and out of hospital); and biomarkers of heart failure (NT-proBNP).METHODSThe study population is 36 cancer survivors with a diagnosis of AIC, left ventricular (LV) ejection fraction ≤40%, and symptoms of heart failure (NYHA class II-III) on optimally-tolerated medical therapy. Subjects must be clinically free of cancer for at least two years with a ≤ 30% estimated five-year risk of recurrence. The first six subjects participated in an open-label, lead-in phase and received 100 million allo-MSCs; the remaining 30 will be randomized 1:1 to receive allo-MSCs or vehicle via 20 transendocardial injections. Efficacy measures (obtained at baseline, 6 months, and 12 months) include MRI evaluation of LV function, LV volumes, fibrosis, and scar burden; assessment of exercise tolerance (six-minute walk test) and quality of life (Minnesota Living with Heart Failure Questionnaire); clinical outcomes (MACE and cumulative days alive and out of hospital); and biomarkers of heart failure (NT-proBNP).This is the first clinical trial using direct cardiac injection of cells for the treatment of AIC. If administration of allo-MSCs is found feasible and safe, SENECA will pave the way for larger phase II/III studies with therapeutic efficacy as the primary outcome.CONCLUSIONSThis is the first clinical trial using direct cardiac injection of cells for the treatment of AIC. If administration of allo-MSCs is found feasible and safe, SENECA will pave the way for larger phase II/III studies with therapeutic efficacy as the primary outcome. ObjectivesSENECA (StEm cell iNjECtion in cAncer survivors) is a phase I, randomized, double-blind, placebo-controlled study to evaluate the safety and feasibility of delivering allogeneic mesenchymal stromal cells (allo-MSCs) transendocardially in subjects with anthracycline-induced cardiomyopathy (AIC).BackgroundAIC is an incurable and often fatal syndrome, with a prognosis worse than that of ischemic or nonischemic cardiomyopathy. Recently, cell therapy with MSCs has emerged as a promising new approach to repair damaged myocardium.MethodsThe study population is 36 cancer survivors with a diagnosis of AIC, left ventricular (LV) ejection fraction ≤40%, and symptoms of heart failure (NYHA class II-III) on optimally-tolerated medical therapy. Subjects must be clinically free of cancer for at least two years with a ≤ 30% estimated five-year risk of recurrence. The first six subjects participated in an open-label, lead-in phase and received 100 million allo-MSCs; the remaining 30 will be randomized 1:1 to receive allo-MSCs or vehicle via 20 transendocardial injections. Efficacy measures (obtained at baseline, 6 months, and 12 months) include MRI evaluation of LV function, LV volumes, fibrosis, and scar burden; assessment of exercise tolerance (six-minute walk test) and quality of life (Minnesota Living with Heart Failure Questionnaire); clinical outcomes (MACE and cumulative days alive and out of hospital); and biomarkers of heart failure (NT-proBNP).ConclusionsThis is the first clinical trial using direct cardiac injection of cells for the treatment of AIC. If administration of allo-MSCs is found feasible and safe, SENECA will pave the way for larger phase II/III studies with therapeutic efficacy as the primary outcome. |
| Author | March, Keith L. Cohen, Michelle Henry, Timothy D. Gee, Adrian P. Sayre, Shelly L. Ebert, Ray F. Simari, Robert D. Hare, Joshua M. Miller, Kathy Willerson, James T. Bolli, Roberto Lenneman, Carrie G. Moyé, Lem Perin, Emerson C. Traverse, Jay H. Vojvodic, Rachel W. Yang, Phillip C. Pepine, Carl J. Bettencourt, Judy Lima, João A. |
| AuthorAffiliation | k UT Health School of Public Health, Houston, TX j Johns Hopkins University, Baltimore, MD a University of Louisville, Louisville, KY g Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, MN c Cedars-Sinai Heart Institute, Los Angeles, California h Stanford University School of Medicine, Stanford, California e University of Florida School of Medicine, Gainesville, Florida m University of Kansas School of Medicine, Kansas City, Kansas d Indiana University School of Medicine, Indianapolis, Indiana f Texas Heart Institute, CHI St. Luke’s Health, Houston, TX b University of Miami Miller School of Medicine, Miami, Florida i Baylor College of Medicine, Houston, TX l NIH, National Heart, Lung, and Blood Institute, Bethesda, MD |
| AuthorAffiliation_xml | – name: c Cedars-Sinai Heart Institute, Los Angeles, California – name: i Baylor College of Medicine, Houston, TX – name: j Johns Hopkins University, Baltimore, MD – name: h Stanford University School of Medicine, Stanford, California – name: g Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, MN – name: a University of Louisville, Louisville, KY – name: m University of Kansas School of Medicine, Kansas City, Kansas – name: f Texas Heart Institute, CHI St. Luke’s Health, Houston, TX – name: k UT Health School of Public Health, Houston, TX – name: b University of Miami Miller School of Medicine, Miami, Florida – name: d Indiana University School of Medicine, Indianapolis, Indiana – name: e University of Florida School of Medicine, Gainesville, Florida – name: l NIH, National Heart, Lung, and Blood Institute, Bethesda, MD |
| Author_xml | – sequence: 1 givenname: Roberto surname: Bolli fullname: Bolli, Roberto organization: University of Louisville, Louisville, KY – sequence: 2 givenname: Joshua M. surname: Hare fullname: Hare, Joshua M. organization: University of Miami Miller School of Medicine, Miami, Florida – sequence: 3 givenname: Timothy D. surname: Henry fullname: Henry, Timothy D. organization: Cedars-Sinai Heart Institute, Los Angeles, California – sequence: 4 givenname: Carrie G. surname: Lenneman fullname: Lenneman, Carrie G. organization: University of Louisville, Louisville, KY – sequence: 5 givenname: Keith L. surname: March fullname: March, Keith L. organization: Indiana University School of Medicine, Indianapolis, Indiana – sequence: 6 givenname: Kathy surname: Miller fullname: Miller, Kathy organization: Indiana University School of Medicine, Indianapolis, Indiana – sequence: 7 givenname: Carl J. surname: Pepine fullname: Pepine, Carl J. organization: University of Florida School of Medicine, Gainesville, Florida – sequence: 8 givenname: Emerson C. surname: Perin fullname: Perin, Emerson C. organization: Texas Heart Institute, CHI St. Luke's Health, Houston, TX – sequence: 9 givenname: Jay H. surname: Traverse fullname: Traverse, Jay H. organization: Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, MN – sequence: 10 givenname: James T. surname: Willerson fullname: Willerson, James T. organization: Texas Heart Institute, CHI St. Luke's Health, Houston, TX – sequence: 11 givenname: Phillip C. surname: Yang fullname: Yang, Phillip C. organization: Stanford University School of Medicine, Stanford, California – sequence: 12 givenname: Adrian P. surname: Gee fullname: Gee, Adrian P. organization: Baylor College of Medicine, Houston, TX – sequence: 13 givenname: João A. surname: Lima fullname: Lima, João A. organization: Johns Hopkins University, Baltimore, MD – sequence: 14 givenname: Lem surname: Moyé fullname: Moyé, Lem email: lemmoye@msn.com organization: UT Health School of Public Health, Houston, TX – sequence: 15 givenname: Rachel W. surname: Vojvodic fullname: Vojvodic, Rachel W. organization: UT Health School of Public Health, Houston, TX – sequence: 16 givenname: Shelly L. surname: Sayre fullname: Sayre, Shelly L. organization: UT Health School of Public Health, Houston, TX – sequence: 17 givenname: Judy surname: Bettencourt fullname: Bettencourt, Judy organization: UT Health School of Public Health, Houston, TX – sequence: 18 givenname: Michelle surname: Cohen fullname: Cohen, Michelle organization: UT Health School of Public Health, Houston, TX – sequence: 19 givenname: Ray F. surname: Ebert fullname: Ebert, Ray F. organization: NIH, National Heart, Lung, and Blood Institute, Bethesda, MD – sequence: 20 givenname: Robert D. surname: Simari fullname: Simari, Robert D. organization: University of Kansas School of Medicine, Kansas City, Kansas |
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