Heart failure & cardiomyopathies
Design and rationale of CATO, a Phase IIA, randomized, double-blind, placebo-controlled study of single or repeated intravenous administration of umbilical cord-derived mesenchymal stromal cells in ischemic cardiomyopathy
Study context
- Population
- Patients with ischemic heart failure (HF) (chronic ischemic cardiomyopathy)planned
- Participants
- 60 patients
- Planned comparison
- Single or 4 repeated IV doses of UC-MSCs vs placebo
Methodological detailsPhase IIA, double-blind, placebo-controlled, multicentre, Enrollment began March 4, 2024; completion expected March 2026, follow-up by March 2027, Evaluation of cardiac function and structure, functional capacity, quality of life and biomarkers over 12 months
- Phase IIA
- Double-blind
- Placebo-controlled
- Multicentre
- Enrollment began March 4, 2024; completion expected March 2026, follow-up by March 2027
- Evaluation of cardiac function and structure, functional capacity, quality of life and biomarkers over 12 months
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Design and rationale of CATO, a Phase IIA, randomized, double-blind, placebo-controlled study of single or repeated intravenous administration of umbilical cord-derived mesenchymal stromal cells in ischemic cardiomyopathy. Am Heart J. Published 13 December 2025. doi:10.
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