Dernière mise à jour: Août 17, 2026
Comparaison des cellules souches mésenchymateuses allogéniques et autologues dérivées de la moelle osseuse délivrées par injection transendocardique chez des patients atteints de cardiomyopathie ischémique: l'essai randomisé POSEIDON.
Cellules souches mésenchymateuses (MSC) sont en cours d'évaluation comme traitement de la cardiomyopathie ischémique (ICM). Des thérapies MSC autologues et allogéniques sont possibles; cependant, 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 (BT) 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 million, ou 200 millions de cellules (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, fraction d'éjection (FE), early enhancement defect (EED; taille de l'infarctus), and sphericity index.
RÉSULTATS:
Dans 30 jours, 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% (n = 5) in the allogeneic group and 53.3% (n = 8) in the autologous group (P = .46). À 1 année, there were no ventricular arrhythmia SAEs observed among allogeneic recipients compared with 4 patients (26.7%) in the autologous group (P = .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%; P. < .001) and sphericity index but did not increase EF. Allogeneic MSCs reduced LV end-diastolic volumes. Low-dose concentration MSCs (20 millions de cellules) 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, qualité de vie, and ventricular remodeling.
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