1. First-in-human PeriCord cardiac bioimplant: Scalability and GMP manufacturing of an allogeneic engineered tissue graft
- Author
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Cristina Prat-Vidal, Luciano Rodríguez-Gómez, Miriam Aylagas, Nuria Nieto-Nicolau, Paloma Gastelurrutia, Elba Agustí, Carolina Gálvez-Montón, Ignasi Jorba, Albert Teis, Marta Monguió-Tortajada, Santiago Roura, Joaquim Vives, Silvia Torrents-Zapata, María Isabel Coca, Laura Reales, María Luisa Cámara-Rosell, Germán Cediel, Ruth Coll, Ramon Farré, Daniel Navajas, Anna Vilarrodona, Joan García-López, Christian Muñoz-Guijosa, Sergi Querol, and Antoni Bayes-Genis
- Subjects
Medicine ,Medicine (General) ,R5-920 - 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 12·5 × 106 viable WJ-MSCs (85·4% cell viability;
- Published
- 2020
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