Implantation of a double allogeneic human engineered tissue graft on damaged heart: insights from the PERISCOPE phase I clinical trialResearch in context
Summary: 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...
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| Format: | Article |
| Language: | English |
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Elsevier
2024-04-01
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| Series: | EBioMedicine |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2352396424000951 |
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| author | 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 Christian Muñoz-Guijosa Sergi Querol |
| author_facet | 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 Christian Muñoz-Guijosa Sergi Querol |
| author_sort | Antoni Bayes-Genis |
| collection | DOAJ |
| description | Summary: 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. 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). |
| first_indexed | 2024-04-24T11:20:58Z |
| format | Article |
| id | doaj.art-042e3b53b8944b1ca3d48e6cbccb5014 |
| institution | Directory Open Access Journal |
| issn | 2352-3964 |
| language | English |
| last_indexed | 2024-04-24T11:20:58Z |
| publishDate | 2024-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EBioMedicine |
| spelling | doaj.art-042e3b53b8944b1ca3d48e6cbccb50142024-04-11T04:41:27ZengElsevierEBioMedicine2352-39642024-04-01102105060Implantation of a double allogeneic human engineered tissue graft on damaged heart: insights from the PERISCOPE phase I clinical trialResearch in contextAntoni Bayes-Genis0Paloma Gastelurrutia1Marta Monguió-Tortajada2Maria Luisa Cámara3Cristina Prat-Vidal4German Cediel5Luciano Rodríguez-Gómez6Albert Teis7Elena Revuelta-López8Gemma Ferrer-Curriu9Santiago Roura10Carolina Gálvez-Montón11Felipe Bisbal12Joaquim Vives13Anna Vilarrodona14Christian Muñoz-Guijosa15Sergi Querol16Heart Institute and Heart Failure Unit (iCor), Germans Trias i Pujol University Hospital (HUGTiP), Badalona, Spain; CIBER Cardiovascular, Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, Autonomous University of Barcelona, Barcelona, Spain; ICREC Research Program, Germans Trias i Pujol Health Science Research Institute (IGTP), Spain; Corresponding author. Heart Institute and Heart Failure Unit, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.Heart Institute and Heart Failure Unit (iCor), Germans Trias i Pujol University Hospital (HUGTiP), Badalona, Spain; CIBER Cardiovascular, Instituto de Salud Carlos III, Madrid, Spain; ICREC Research Program, Germans Trias i Pujol Health Science Research Institute (IGTP), SpainHeart Institute and Heart Failure Unit (iCor), Germans Trias i Pujol University Hospital (HUGTiP), Badalona, Spain; ICREC Research Program, Germans Trias i Pujol Health Science Research Institute (IGTP), SpainHeart Institute and Heart Failure Unit (iCor), Germans Trias i Pujol University Hospital (HUGTiP), Badalona, SpainCell Therapy Service, Banc de Sang i Teixits (BST), Barcelona, SpainHeart Institute and Heart Failure Unit (iCor), Germans Trias i Pujol University Hospital (HUGTiP), Badalona, Spain; CIBER Cardiovascular, Instituto de Salud Carlos III, Madrid, SpainCell Therapy Service, Banc de Sang i Teixits (BST), Barcelona, SpainHeart Institute and Heart Failure Unit (iCor), Germans Trias i Pujol University Hospital (HUGTiP), Badalona, SpainHeart Institute and Heart Failure Unit (iCor), Germans Trias i Pujol University Hospital (HUGTiP), Badalona, Spain; CIBER Cardiovascular, Instituto de Salud Carlos III, Madrid, Spain; ICREC Research Program, Germans Trias i Pujol Health Science Research Institute (IGTP), SpainCIBER Cardiovascular, Instituto de Salud Carlos III, Madrid, SpainHeart Institute and Heart Failure Unit (iCor), Germans Trias i Pujol University Hospital (HUGTiP), Badalona, Spain; CIBER Cardiovascular, Instituto de Salud Carlos III, Madrid, Spain; ICREC Research Program, Germans Trias i Pujol Health Science Research Institute (IGTP), Spain; Faculty of Medicine, University of Vic-Central University of Catalonia (UVic-UCC), Victoria, SpainHeart Institute and Heart Failure Unit (iCor), Germans Trias i Pujol University Hospital (HUGTiP), Badalona, Spain; CIBER Cardiovascular, Instituto de Salud Carlos III, Madrid, Spain; ICREC Research Program, Germans Trias i Pujol Health Science Research Institute (IGTP), SpainHeart Institute and Heart Failure Unit (iCor), Germans Trias i Pujol University Hospital (HUGTiP), Badalona, Spain; CIBER Cardiovascular, Instituto de Salud Carlos III, Madrid, SpainDepartment of Medicine, Autonomous University of Barcelona, Barcelona, Spain; Cell Therapy Service, Banc de Sang i Teixits (BST), Barcelona, Spain; Vall d’Hebron Institute of Research (VHIR), Autonomous University of Barcelona, Barcelona, SpainBarcelona Tissue Bank (BTB), Banc de Sang i Teixits (BST), Barcelona, SpainHeart Institute and Heart Failure Unit (iCor), Germans Trias i Pujol University Hospital (HUGTiP), Badalona, Spain; CIBER Cardiovascular, Instituto de Salud Carlos III, Madrid, SpainCell Therapy Service, Banc de Sang i Teixits (BST), Barcelona, Spain; Corresponding author. Cell Therapy Service, Banc de Sang i Teixits (BST), Barcelona, Spain.Summary: 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. 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).http://www.sciencedirect.com/science/article/pii/S2352396424000951Cardiac repairCardiac regenerationEngineered tissueCardiac tissue engineeringDecellularised tissueMyocardial infarction |
| spellingShingle | 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 Christian Muñoz-Guijosa Sergi Querol Implantation of a double allogeneic human engineered tissue graft on damaged heart: insights from the PERISCOPE phase I clinical trialResearch in context EBioMedicine Cardiac repair Cardiac regeneration Engineered tissue Cardiac tissue engineering Decellularised tissue Myocardial infarction |
| title | Implantation of a double allogeneic human engineered tissue graft on damaged heart: insights from the PERISCOPE phase I clinical trialResearch in context |
| title_full | Implantation of a double allogeneic human engineered tissue graft on damaged heart: insights from the PERISCOPE phase I clinical trialResearch in context |
| title_fullStr | Implantation of a double allogeneic human engineered tissue graft on damaged heart: insights from the PERISCOPE phase I clinical trialResearch in context |
| title_full_unstemmed | Implantation of a double allogeneic human engineered tissue graft on damaged heart: insights from the PERISCOPE phase I clinical trialResearch in context |
| title_short | Implantation of a double allogeneic human engineered tissue graft on damaged heart: insights from the PERISCOPE phase I clinical trialResearch in context |
| title_sort | implantation of a double allogeneic human engineered tissue graft on damaged heart insights from the periscope phase i clinical trialresearch in context |
| topic | Cardiac repair Cardiac regeneration Engineered tissue Cardiac tissue engineering Decellularised tissue Myocardial infarction |
| url | http://www.sciencedirect.com/science/article/pii/S2352396424000951 |
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