Prat Vidal, CristinaRodríguez Gomez, LucianoAylagas, MiriamNieto Nicolau, NúriaGastelurrutia, PalomaAgustí, ElbaGálvez Montón, CarolinaJorba, IgnasiTeis, AlbertMonguió Tortajada, MartaRoura, SantiagoVives, JoaquimTorrents Zapata, SilviaCoca, María IsabelReales, LauraCámara Rosell, María LuisaCediel, GermánColl, RuthFarré Ventura, RamonNavajas Navarro, DanielVilarrodona, AnnaGarcía López, JoanMuñoz Guijosa, ChristianQuerol Giner, SergiBayés Genís, Antoni2021-07-212021-07-212020-04-012352-3964https://hdl.handle.net/2445/179267Background: 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 12·5 × 106 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 PeriCord cardiac bioimplant, and its first-in-human implantation.11 p.application/pdfengcc-by (c) Prat Vidal, Cristina et al., 2020https://creativecommons.org/licenses/by/4.0/Cirurgia cardiovascularInfart de miocardiCardiovascular surgeryMyocardial infarctioninfo:eu-repo/semantics/article7058172021-07-21info:eu-repo/semantics/openAccess32304998