Nanostructured fibrin-agarose hydrogels loaded with allogeneic fibroblasts as bio-dressings for acute treatment of massive burns Arribas-Arribas, Blanca Fernandez-Muñoz, Beatriz Campos Cuerva, Rafael Montiel-Aguilera, Miguel Ángel Bermejo-Gonzalez, María Lomas-Romero, Isabel Martín-López, María Alcázar-Caballero, Rosario Mata Macías-Sánchez, María del Mar Campos Sánchez, Fernando Alaminos Mingorance, Miguel Gómez-Cía, Tomás Gacto, Purificación Carmona, Gloria Santos González, Mónica Allogeneic Graft Burn Skin Fibroblasts Nanostructuration This work was supported by research funds from the Andalusian Consejería de Salud y Familias to the Red Andaluza de Diseño y Traslación de Terapias Avanzadas. The study was also partially supported by the Consejería de Salud y Familias, Junta de Andalucía, Spain, and the Programa Operativo FEDER Andalucía 2014–2020, University of Granada and Consejería de Transformación Económica, Industria, Conocimiento y Universidades (grant numbers: PE-0395–2019 and B-CTS-450-UGR20). Unidad de Producción y Reprogramación Celular for technical help and support. The prompt management of patients with massive burns is essential to maximize survival by preventing infection, hemorrhage, fluid and heat loss, and to optimally prepare the wound bed for the application of autografts or cultured tissue-engineered artificial autologous skin. Acute treatments are typically based on temporary bio-dressings, commonly cadaveric skin allografts, but supply challenges, high costs and increasingly stringent regulatory requirements preclude their widespread use. Nanostructured fibrin-agarose hydrogels (NFAH) have been proven to be safe and effective biomaterials in preclinical and clinical studies, and show good hemostatic and biomechanical properties. Here we generated and tested NFAH with embedded allogeneic dermal fibroblasts (NFAH-F) under Good Manufacturing Practice (GMP) conditions. Fibroblasts were first expanded and characterized to create a GMP bank and the NFAH-F was manufactured on demand. Three patients with major burns were treated with this product as a temporary bio-dressing under compassionate use. Our results suggest that NFAH-F product was a safe product and no adverse reactions were observed. In all cases, the patients survived until definitive treatment. Therefore, the application of NFAH-F might be a temporary bio-dressing for patients with massive burns when cadaveric skin allografts are not available. 2024-02-27T10:43:15Z 2024-02-27T10:43:15Z 2023-12 journal article Blanca Arribas-Arribas, Beatriz Fernández-Muñoz, Rafael Campos-Cuerva, et al. Nanostructured fibrin-agarose hydrogels loaded with allogeneic fibroblasts as bio-dressings for acute treatment of massive burns. Biomedicine & Pharmacotherapy. 2023,168:115769. https://doi.org/10.1016/j.biopha.2023.115769 https://hdl.handle.net/10481/89618 10.1016/j.biopha.2023.115769 eng http://creativecommons.org/licenses/by/4.0/ open access Atribución 4.0 Internacional Elsevier