Ready-To-Use Investigational Stem Cells, MiSaver, in Patients with Recent Acute Myocardial Infarction, 1 year follow up from a Phase 1 Safety Study
Notice bibliographique
Résumé
Abstract Objectives The aim of this study was to investigate the safety of MiSaver stem cells and their preliminary efficacy in improving left ventricular ejection function and functional activity in patients with acute myocardial infarction (AMI) Background Cardiovascular diseases (CVDs) are the leading cause of death globally. In 2019, an estimated 17.9 million people died from CVDs, accounting for 32% of all global deaths. Among these deaths, 85% were due to heart attacks and strokes. Left ventricular ejection fraction (LVEF) recovery after myocardial infarction (MI) is an important prognostic indicator, and patients who do not recover LVEF after MI are at high risk of sudden cardiac arrest events and death. Stem cell therapy holds promise for cardiovascular diseases, offering regenerative potential through cell differentiation. However, limited access exists for clinicians and patients. This study investigates the safety and efficacy of MiSaver (Myocardial Infarction Functional Saver), a prefabricated stem cell investigational product, in recent AMI patients. Findings contribute to advancing stem cell treatments, improving accessibility and patient outcomes. Methods Patients who were admitted for AMI within 7 days and had reduced LVEF (.45%) were eligible for the study. MiSaver were matched for blood group and administered in participants in cohorts of five, each receiving escalating dosages (0.5×10^7, 1.6×10^7, and 5.0×10^7 cells/kg, respectively). Patients were assessed for symptoms of graft-versus-host disease (GVHD) and treatment-related adverse events (AE). LVEF measured by echocardiographic on admission, at 6 months, and at 12 months after treatment. Patients functional activity status evalution ( using the New York Heart Association (NYHA) and Canadian Cardiovascular Society (CCS) classification systems. Results Out of the initially planned 15 participants, eleven were enrolled in the study. The trial was halted prematurely due to challenges associated with the COVID-19 pandemic and impractical transportation logistics. Patients received MiSaver infusions within 2-5 days post-AMI onset. During the 12-month follow-up period, no study-related adverse events or signs of graft-versus-host disease were reported. At 12 months post-treatment, both the low and middle dose groups, as well as participant 11, showed improved LVEF, accompanied by enhanced Canadian Cardiovascular Society (CCS) class grades compared to baseline. Conclusion The intravenous infusion of MiSaver stem cells in AMI patients demonstrated safety and tolerability for low and middle dosage groups. The study provides promising insights into the potential of stem cells therapy in improving left ventricular function following AMI. However, further research with larger cohorts and a controlled placebo is warranted to confirm these findings and address limitations encountered during this trial.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».