Implantation of a double allogeneic human engineered tissue graft on damaged heart: insights from the PERISCOPE phase I clinical trial

在受损心脏上植入双同种异体人体工程组织移植物:PERISCOPE I 期临床试验的见解

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作者:Antoni Bayes-Genis, Paloma Gastelurrutia, Marta Monguió-Tortajada, Maria Luisa Cámara, Cristina Prat-Vidal, German Cediel, Luciano Rodríguez-Gómez, Albert Teis, Elena Revuelta-López, Gemma Ferrer-Curriu, Santiago Roura, Carolina Gálvez-Montón, Felipe Bisbal, Joaquim Vives, Anna Vilarrodona, Christia

Background

In preclinical studies, the use of double allogeneic grafts has shown promising

Methods

This was a double-blind, single-centre trial that enrolled patients with non-acute myocardial infarction eligible for surgical revascularization. Seven patients were implanted with PeriCord while five served as controls. Findings: Patients who received PeriCord showed no adverse effects during post-operative phase and one-year follow-up. No significant changes in secondary outcomes, such as quality of life or cardiac function, were found in patients who received PeriCord. However, PeriCord did modulate the kinetics of circulating monocytes involved in post-infarction myocardial repair towards non-classical inflammation-resolving macrophages, as well as levels of monocyte chemoattractants and the prognostic marker Meteorin-like in plasma following treatment. Interpretation: In summary, the PeriCord graft has exhibited a safe profile and notable immunomodulatory properties. Nevertheless, further research is required to fully unlock its potential as a platform for managing inflammatory-related pathologies. Funding: This work was supported in part by grants from MICINN (SAF2017-84324-C2-1-R); Instituto de Salud Carlos III (ICI19/00039 and Red RICORS-TERAV RD21/0017/0022, and CIBER Cardiovascular CB16/11/00403) as a part of the Plan Nacional de I + D + I, and co-funded by ISCIII-Subdirección General de Evaluación y el Fondo Europeo de Desarrollo Regional (FEDER) and AGAUR (2021-SGR-01437).

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