Please use this identifier to cite or link to this item: http://hdl.handle.net/2445/158777
Title: First-in-human PeriCord cardiac bioimplant: Scalability and GMP manufacturing of an allogeneic engineered tissue graft
Author: Prat Vidal, Cristina
Rodríguez Gómez, Luciano
Aylagas, Miriam
Nieto-Nicolau, Nuria
Gastelurrutia, Paloma
Agustí, Elba
Gálvez Montón, Carolina
Jorba, Ignasi
Teis, Albert
Monguió Tortajada, Marta
Roura, Santiago
Vives, Joaquim
Torrents Zapata, Silvia
Coca, María Isabel
Reales, Laura
Cámara Rosell, María Luisa
Cediel, Germán
Coll, Ruth
Farré, Ramon
Navajas Navarro, Daniel
Vilarrodona, Anna
García López, Joan
Muñoz Guijosa, Christian
Querol, Sergi
Bayes Genis, Antoni
Keywords: Implants artificials
Enginyeria de teixits
Infart de miocardi
Artificial implants
Tissue engineering
Myocardial infarction
Issue Date: 1-Apr-2020
Publisher: Elsevier B. V.
Abstract: Background: Small cardiac tissue engineering constructs show promise for limiting post-infarct sequelae in animal models. This study sought to scale-up a 2-cm2 preclinical construct into a human-size advanced therapy medicinal product (ATMP; PeriCord), and to test it in a first-in-human implantation. Methods: The PeriCord is a clinical-size (12-16 cm2) 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. Findings: 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-cm2 pericardial scaffold contained 12.5E6 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. Interpretation: This preliminary report describes the development of a scalable clinical-size allogeneic Peri- Cord cardiac bioimplant, and its first-in-human implantation. Funding: 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.
Note: Reproducció del document publicat a: https://doi.org/10.1016/j.ebiom.2020.102729
It is part of: EBioMedicine, 2020, vol. 54, p. 102729
URI: http://hdl.handle.net/2445/158777
Related resource: https://doi.org/10.1016/j.ebiom.2020.102729
Appears in Collections:Articles publicats en revistes (Institut de Bioenginyeria de Catalunya (IBEC))
Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

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