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Am Heart J. 2018 Jul;201:54-62. doi: 10.1016/j.ahj.2018.02.009. Epub 2018 Apr 4.

Rationale and Design of the SENECA (StEm cell iNjECtion in cAncer survivors) Trial.

Author information

1
University of Louisville, Louisville, KY.
2
University of Miami Miller School of Medicine, Miami, Florida.
3
Cedars-Sinai Heart Institute, Los Angeles, California.
4
Indiana University School of Medicine, Indianapolis, Indiana.
5
University of Florida School of Medicine, Gainesville, Florida.
6
Texas Heart Institute, CHI St. Luke's Health, Houston, TX.
7
Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, MN.
8
Stanford University School of Medicine, Stanford, California.
9
Baylor College of Medicine, Houston, TX.
10
Johns Hopkins University, Baltimore, MD.
11
UT Health School of Public Health, Houston, TX. Electronic address: lemmoye@msn.com.
12
UT Health School of Public Health, Houston, TX.
13
NIH, National Heart, Lung, and Blood Institute, Bethesda, MD.
14
University of Kansas School of Medicine, Kansas City, Kansas.

Abstract

OBJECTIVES:

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).

BACKGROUND:

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.

METHODS:

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).

CONCLUSIONS:

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02509156.

PMID:
29910056
DOI:
10.1016/j.ahj.2018.02.009
[Indexed for MEDLINE]

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