Web of Science: 1 cites, Scopus: 1 cites, Google Scholar: cites,
First-in-human PeriCord cardiac bioimplant : Scalability and GMP manufacturing of an allogeneic engineered tissue graft
Prat-Vidal, Cristina (Institut d'Investigació Biomèdica de Bellvitge - IDIBELL, L'Hospitalet de Llobregat, Spain)
Rodríguez-Gómez, Luciano (Cell Therapy Service, Banc de Sang i Teixits, Edifici Dr. Frederic Duran i Jordà, Passeig Taulat, 116, 08005 Barcelona, Spain)
Aylagas, Miriam (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Nieto-Nicolau, Nuria (Barcelona Tissue Bank (BTB), Banc de Sang i Teixits (BST), Barcelona, Spain)
Gastelurrutia, Paloma (Institut d'Investigació Biomèdica de Bellvitge - IDIBELL, L'Hospitalet de Llobregat, Spain)
Agustí, Elba (Barcelona Tissue Bank (BTB), Banc de Sang i Teixits (BST), Barcelona, Spain)
Gálvez-Montón, Carolina (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Jorba, Ignasi (Institute for Bioengineering of Catalonia (IBEC), The Barcelona Institute of Science and Technology, CIBERES, University of Barcelona, Barcelona, Spain)
Teis, Albert (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Monguió-Tortajada, Marta (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Roura, Santiago (CIBER Cardiovascular, Instituto de Salud Carlos III, Madrid, Spain)
Vives Armengol, Joaquim (Universitat Autònoma de Barcelona. Departament de Medicina)
Torrents-Zapata, Silvia (Cell Therapy Service, Banc de Sang i Teixits, Edifici Dr. Frederic Duran i Jordà, Passeig Taulat, 116, 08005 Barcelona, Spain)
Coca, María Isabel (Cell Therapy Service, Banc de Sang i Teixits, Edifici Dr. Frederic Duran i Jordà, Passeig Taulat, 116, 08005 Barcelona, Spain)
Reales, Laura (Cell Therapy Service, Banc de Sang i Teixits, Edifici Dr. Frederic Duran i Jordà, Passeig Taulat, 116, 08005 Barcelona, Spain)
Cámara-Rosell, María Luisa (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Cediel, Germán (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Coll, Ruth (Research and Education. Banc de Sang i Teixits, Edifici Dr. Frederic Duran i Jordà, Passeig Taulat, 116, 08005 Barcelona, Spain)
Farré, Ramon (Unit of Biophysics and Bioengineering, School of Medicine and Health Sciences, University of Barcelona-IDIBAPS-CIBERES, Barcelona, Spain)
Navajas, Daniel (Institute for Bioengineering of Catalonia (IBEC), The Barcelona Institute of Science and Technology, CIBERES, University of Barcelona, Barcelona, Spain)
Vilarrodona, Anna (Barcelona Tissue Bank (BTB), Banc de Sang i Teixits (BST), Barcelona, Spain)
García-López, Joan (Research and Education. Banc de Sang i Teixits, Edifici Dr. Frederic Duran i Jordà, Passeig Taulat, 116, 08005 Barcelona, Spain)
Muñoz-Guijosa, Christian (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Querol, Sergi (Transfusional Medicine Group, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona, Spain)
Bayes-Genis, Antoni (Universitat Autònoma de Barcelona. Departament de Medicina)

Data: 2020
Resum: Small cardiac tissue engineering constructs show promise for limiting post-infarct sequelae in animal models. This study sought to scale-up a 2-cm 2 preclinical construct into a human-size advanced therapy medicinal product (ATMP; PeriCord), and to test it in a first-in-human implantation. The PeriCord is a clinical-size (12-16 cm 2) decellularised pericardial matrix colonised with human viable Wharton's jelly-derived mesenchymal stromal cells (WJ-MSCs). WJ-MSCs expanded following good manufacturing practices (GMP) met safety and quality standards regarding the number of cumulative population doublings, genomic stability, and sterility. Human decellularised pericardial scaffolds were tested for DNA content, matrix stiffness, pore size, and absence of microbiological growth. PeriCord implantation was surgically performed on a large non-revascularisable scar in the inferior wall of a 63-year-old male patient. Coronary artery bypass grafting was concomitantly performed in the non-infarcted area. At implantation, the 16-cm 2 pericardial scaffold contained 12·5 × 10 6 viable WJ-MSCs (85·4% cell viability; <0·51 endotoxin units (EU)/mL). Intraoperative PeriCord delivery was expeditious, and secured with surgical glue. The post-operative course showed non-adverse reaction to the PeriCord, without requiring host immunosuppression. The three-month clinical follow-up was uneventful, and three-month cardiac magnetic resonance imaging showed ~9% reduction in scar mass in the treated area. This preliminary report describes the development of a scalable clinical-size allogeneic PeriCord cardiac bioimplant, and its first-in-human implantation. La Marató de TV3 Foundation, Government of Catalonia, Catalan Society of Cardiology, "La Caixa" Banking Foundation, Spanish Ministry of Science, Innovation and Universities, Institute of Health Carlos III, and the European Regional Development Fund.
Nota: Altres ajuts: La Marató de TV3 Foundation, Government of Catalonia, Catalan Society of Cardiology, "La Caixa" Banking Foundation, Spanish Ministry of Science, Innovation and Universities, Institute of Health Carlos III, and the European Regional Development Fund.
Drets: 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. Creative Commons
Llengua: Anglès
Document: article ; recerca ; publishedVersion
Matèria: Wharton's jelly-derived mesenchymal stromal cells (WJ-MSCs) ; Biofabrication ; Advanced therapy medicinal product (ATMP) ; Cardiac tissue engineering ; Scaffold ; Myocardial infarction
Publicat a: EBioMedicine, Vol. 54 (april 2020) , ISSN 2352-3964

DOI: 10.1016/j.ebiom.2020.102729
PMID: 32304998


11 p, 2.3 MB

El registre apareix a les col·leccions:
Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Articles > Articles de recerca
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 Registre creat el 2020-07-13, darrera modificació el 2021-01-07



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