Implantation of a double allogeneic human engineered tissue graft on damaged heart : insights from the PERISCOPE phase I clinical trial
Bayés-Genís, Antoni (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Gastelurrutia, Paloma (Institut Germans Trias i Pujol)
Monguió-Tortajada, Marta (Institut Germans Trias i Pujol)
Cámara, Maria-Luisa (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Prat-Vidal, Cristina (Universitat Autònoma de Barcelona. Banc de Sang i Teixits)
Cediel, Germán (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Rodríguez-Gómez, Luciano (Universitat Autònoma de Barcelona. Banc de Sang i Teixits)
Teis, Albert (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Revuelta-López, Elena (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Ferrer-Curriu, Gemma (Instituto de Salud Carlos III)
Roura, Santiago (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Gálvez-Montón, Carolina (Institut Germans Trias i Pujol)
Bisbal, Felipe (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Vives Armengol, Joaquim (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Vilarrodona, Anna (Institut de Recerca Sant Pau)
Muñoz-Guijosa, Christian (Instituto de Salud Carlos III)
Querol, Sergi (Universitat Autònoma de Barcelona. Banc de Sang i Teixits)

Date:	2024
Abstract:	Background: In preclinical studies, the use of double allogeneic grafts has shown promising results in promoting tissue revascularization, reducing infarct size, preventing adverse remodelling and fibrosis, and ultimately enhancing cardiac function. Building upon these findings, the safety of PeriCord, an engineered tissue graft consisting of a decellularised pericardial matrix and umbilical cord Wharton's jelly mesenchymal stromal cells, was evaluated in the PERISCOPE Phase I clinical trial (NCT03798353), marking its first application in human subjects. 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.
Grants:	Agencia Estatal de Investigación SAF2017-84324-C2-1-R Instituto de Salud Carlos III ICI19/00039 Agència de Gestió d'Ajuts Universitaris i de Recerca 2021/SGR-01437
Note:	This work was supported in part by grants from MICINN, Instituto de Salud Carlos III and Spanish national research networks. They had no role at all in the study design, data collection, data analyses, interpretation or writing of this report.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Published in:	EBioMedicine, Vol. 102 (april 2024) , p. 105060, ISSN 2352-3964

DOI: 10.1016/j.ebiom.2024.105060
PMID: 38490102

10 p, 757.2 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles