Adipose tissue-derived mesenchymal stromal cell therapy in nonischemic heart failure with reduced ejection fraction - ARIISE study design.

Several human studies show positive signals, while research methods and sample sizes continue to develop.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Heart failure (HF) remains a major clinical and healthcare challenge with high morbidity, mortality, and impaired quality of life (QOL). Approximately 30-40% of HF cases in the western world are of nonischemic heart failure (NIHF) origin; yet, regenerative therapies are lacking. Evidence suggests that systemic inflammation contributes to disease progression in NIHF, highlighting immunomodulation as a potential therapeutic target. Mesenchymal stromal cells (MSCs) possess regenerative and immunomodulatory properties, with adipose tissue derived stromal cells (ASCs) emerging as particularly promising. ARIISE is a Danish, multicenter, randomized, double-blinded, placebo-controlled study evaluating the efficacy and safety of intravenous allogeneic ASC therapy (C2C_ASC110) in patients with NIHF and reduced left ventricular ejection fraction (LVEF ≤ 45%). Ninety patients will be randomized to receive either C2C_ASC110 or placebo dimethyl sulfoxide (DMSO) (Cryostor®) intravenously twice 1 month apart, in addition to optimal guideline-directed medical therapy. The primary endpoint is a change in LVEF at 6-month follow-up after second ASC/placebo infusion. Secondary endpoints include other echocardiographic measurements, functional capacity, biomarkers, quality of life (QOL), and safety outcomes. If successful, ARIISE may establish clinical evidence for intravenous ASC therapy as a safe,

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

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