آخر تحديث: أغسطس 17, 2026
Comparison of allogeneic vs autologous bone marrow–derived mesenchymal stem cells delivered by transendocardial injection in patients with ischemic cardiomyopathy: the POSEIDON randomized trial.
الخلايا الجذعية الوسيطة (اللجان الدائمة) are under evaluation as a therapy for ischemic cardiomyopathy (آي سي إم). Both autologous and allogeneic MSC therapies are possible; لكن, their safety and efficacy have not been compared.
OBJECTIVE:
To test whether allogeneic MSCs are as safe and effective as autologous MSCs in patients with left ventricular (LV) dysfunction due to ICM.
DESIGN, SETTING, AND PATIENTS:
A phase 1/2 randomized comparison (POSEIDON study) in a US tertiary-care referral hospital of allogeneic and autologous MSCs in 30 patients with LV dysfunction due to ICM between April 2, 2010, and September 14, 2011, with 13-month follow-up.
INTERVENTION:
Twenty million, 100 مليون, أو 200 million cells (5 patients in each cell type per dose level) were delivered by transendocardial stem cell injection into 10 LV sites.
MAIN OUTCOME MEASURES:
Thirty-day postcatheterization incidence of predefined treatment-emergent serious adverse events (SAEs). Efficacy assessments included 6-minute walk test, exercise peak VO2, Minnesota Living with Heart Failure Questionnaire (MLHFQ), New York Heart Association class, LV volumes, جزء القذف (إي إف), early enhancement defect (EED; infarct size), and sphericity index.
نتائج:
Within 30 أيام, 1 patient in each group (treatment-emergent SAE rate, 6.7%) was hospitalized for heart failure, less than the prespecified stopping event rate of 25%. The 1-year incidence of SAEs was 33.3% (ن = 5) in the allogeneic group and 53.3% (ن = 8) in the autologous group (ف = .46). في 1 سنة, there were no ventricular arrhythmia SAEs observed among allogeneic recipients compared with 4 مرضى (26.7%) in the autologous group (ف = .10). Relative to baseline, autologous but not allogeneic MSC therapy was associated with an improvement in the 6-minute walk test and the MLHFQ score, but neither improved exercise VO2 max. Allogeneic and autologous MSCs reduced mean EED by −33.21% (95% CI, −43.61% to −22.81%; ص < .001) and sphericity index but did not increase EF. Allogeneic MSCs reduced LV end-diastolic volumes. Low-dose concentration MSCs (20 million cells) produced greatest reductions in LV volumes and increased EF. Allogeneic MSCs did not stimulate significant donor-specific alloimmune reactions.
CONCLUSIONS:
In this early-stage study of patients with ICM, transendocardial injection of allogeneic and autologous MSCs without a placebo control were both associated with low rates of treatment-emergent SAEs, including immunologic reactions. In aggregate, MSC injection favorably affected patient functional capacity, نوعية الحياة, and ventricular remodeling.
مراجعة الحالة العلمية
هل ترغب في فهم ما إذا كانت البرامج السريرية الحالية, التطورات البحثية الأخيرة, أو قد تكون النهج الناشئة ذات الصلة بحالتك الفردية?
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- مراجعة المعلومات التي تقدمها
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المعلومات التعليمية والبحثية فقط. هذه الخدمة لا تشكل نصيحة طبية, تشخبص, روشتة, أو شخصية توصية العلاج.
