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Mesenchymal Precursor Cells · AMICI
Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infarction
Ensayo de MESOBLAST LTD en Acute Myocardial Infarction (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 106
- Fin del objetivo primario
- abr 2021
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en mar 2013.
Qué mide
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (del registro, en inglés) (hasta unos 8 años)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis was a double-blind, randomized, placebo-controlled study that was designed to enroll a total of 225 participants with de novo anterior wall acute ST-segment elevation myocardial infarction (STEMI) due to a lesion of the left anterior descending coronary artery undergoing percutaneous coronary intervention (PCI). Eligible participants were to be enrolled and undergo revascularization of the culprit left anterior descending (LAD) coronary artery. The interventional procedure included as dose ranging assessment of intracoronary (IC) delivery of MPC or placebo infused into the stented coronary artery. This study compared two doses of MPCs and a placebo control group. Study participants were randomly assigned in 1:1:1 fashion to receive either 12.5 Million or 25 Million MPCs or placebo (saline). Initially, each group was designed to have approximately 75 patients per treatment group. The Primary Objective of the study was to determine the safety and feasibility of IC infusion of investigational MPCs in this acute STEMI population. The Primary Objective of the study was to determine the safety and feasibility of IC infusion of investigational MPCs in this acute STEMI population. Feasibility of the infusion of the investigational agent was assessed by measurement of thrombolysis in myocardial infarction (TIMI) flow and perfusion (1) immediately prior to, (2) during (after approximately 50% of total investigational agent volume infused) and (3) following the investigational agent infusion after successful PCI and stenting. There was no evidence of clinically important coronary microvascular obstruction related to infusion of the investigational agent.
Más ensayos de MESO
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Rexlemestrocel-L + HA mixture · HyaluronicAcid | Fase 3 | En marcha, sin reclutar | jul 2027 (prevista) |
| Remestemcel-L-rknd | Fase 3 | Aún sin reclutar | feb 2028 (prevista) |
| Rexlemestrocel-L · MSB-DR003 | Fase 3 | Completado | may 2020 (real) |
| Rexlemestrocel-L · DREAM HF-1 | Fase 3 | Completado | ene 2020 (real) |
| Remestemcel-L | Fase 3 | Completado | jun 2018 (real) |
| remestemcel-L | Fase 3 | Completado | abr 2018 (real) |
Todos los de MESO, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01781390), actualizada en jun 2022.