آخر تحديث: أغسطس 17, 2026
خلفية
Anthracycline-induced cardiomyopathy (AIC) may be irreversible with a poor prognosis, disproportionately affecting women and young adults. Administration of allogeneic bone marrow–derived mesenchymal stromal cells (allo-MSCs) is a promising approach to heart failure (التردد العالي) علاج.
أهداف
SENECA (Stem Cell Injection in Cancer Survivors) was a phase 1 study of allo-MSCs in AIC.
طُرق
Cancer survivors with chronic AIC (متوسط العمر 56.6 سنين; 68% women; NT-proBNP 1,426 pg/ml; 6 enrolled in an open-label, lead-in phase and 31 subjects randomized 1:1) received 1 × 108 allo-MSCs or vehicle transendocardially. Primary objectives were safety and feasibility. Secondary efficacy measures included cardiac function and structure measured by cardiac magnetic resonance imaging (CMR), functional capacity, نوعية الحياة (مينيسوتا الذين يعيشون مع استبيان قصور القلب), and biomarkers.
نتائج
ما مجموعه 97% of subjects underwent successful study product injections; all allo-MSC–assigned subjects received the target dose of cells. Follow-up visits were well-attended (92%) with successful collection of endpoints in 94% at the 1-year visit. Although 58% of subjects had non-CMR compatible devices, CMR endpoints were successfully collected in 84% of subjects imaged at 1 سنة. No new tumors were reported. There were no significant differences between allo-MSC and vehicle groups with regard to clinical outcomes. Secondary measures included 6-min walk test (p = 0.056) and Minnesota Living with Heart Failure Questionnaire score (p = 0.048), which tended to favor the allo-MSC group.
الاستنتاجات
In this first-in-human study of cell therapy in patients with AIC, transendocardial administration of allo-MSCs appears safe and feasible, and CMR was successfully performed in the majority of the HF patients with devices. This study lays the groundwork for phase 2 trials aimed at assessing efficacy of cell therapy in patients with AIC. (Stem Cell Injection in Cancer Survivors [SENECA]; NCT02509156)
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المعلومات التعليمية والبحثية فقط. هذه الخدمة لا تشكل نصيحة طبية, تشخبص, روشتة, أو شخصية توصية العلاج.
