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Phase I-IIa clinical trial to evaluate the safety, feasibility and efficacy of the use of a palate mucosa generated by tissue engineering for the treatment of children with cleft palate: the BIOCLEFT study protocol.

Autor: España-López A; Craniofacial Malformations and Cleft Lip and Palate Management Unit (Unidad de Fisurados Labiopalatinos y Malformaciones Craneofaciales), University Hospital Virgen de las Nieves, Granada, Spain.; Department of Stomatology, Faculty of Dentistry, University of Granada, Granada, Spain., Fernández-Valadés R; Craniofacial Malformations and Cleft Lip and Palate Management Unit (Unidad de Fisurados Labiopalatinos y Malformaciones Craneofaciales), University Hospital Virgen de las Nieves, Granada, Spain.; Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.; Division of Pediatric Surgery, University Hospital Virgen de las Nieves, Granada, Spain.; Tissue Engineering Group, Department of Histology, Faculty of Medicine, University of Granada, Granada, Spain., Cubiles E; Fundación para la Investigación Biosanitaria de Andalucía Oriental (FIBAO), Granada, Spain.; Andalusian Network for the Design and Translation of Advanced Therapies (And&tAT/RAdytTA) - Fundación Andaluza Progreso y Salud, MP. Junta de Andalucía, Seville, Spain., Garzón I; Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.; Tissue Engineering Group, Department of Histology, Faculty of Medicine, University of Granada, Granada, Spain., Martin-Piedra MA; Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.; Tissue Engineering Group, Department of Histology, Faculty of Medicine, University of Granada, Granada, Spain., Carriel V; Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.; Tissue Engineering Group, Department of Histology, Faculty of Medicine, University of Granada, Granada, Spain., Campos F; Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.; Tissue Engineering Group, Department of Histology, Faculty of Medicine, University of Granada, Granada, Spain., Martínez-Plaza A; Craniofacial Malformations and Cleft Lip and Palate Management Unit (Unidad de Fisurados Labiopalatinos y Malformaciones Craneofaciales), University Hospital Virgen de las Nieves, Granada, Spain.; Division of Oral and Maxillofacial Surgery, University Hospital Virgen de las Nieves, Granada, Spain., Vallejo D; Craniofacial Malformations and Cleft Lip and Palate Management Unit (Unidad de Fisurados Labiopalatinos y Malformaciones Craneofaciales), University Hospital Virgen de las Nieves, Granada, Spain.; Division of Pediatric Surgery, University Hospital Virgen de las Nieves, Granada, Spain., Liceras-Liceras E; Craniofacial Malformations and Cleft Lip and Palate Management Unit (Unidad de Fisurados Labiopalatinos y Malformaciones Craneofaciales), University Hospital Virgen de las Nieves, Granada, Spain.; Division of Pediatric Surgery, University Hospital Virgen de las Nieves, Granada, Spain., Chato-Astrain J; Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.; Tissue Engineering Group, Department of Histology, Faculty of Medicine, University of Granada, Granada, Spain., García-García OD; Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.; Tissue Engineering Group, Department of Histology, Faculty of Medicine, University of Granada, Granada, Spain., Sánchez-Porras D; Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.; Tissue Engineering Group, Department of Histology, Faculty of Medicine, University of Granada, Granada, Spain., Ávila-Fernández P; Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.; Tissue Engineering Group, Department of Histology, Faculty of Medicine, University of Granada, Granada, Spain., Etayo-Escanilla M; Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.; Tissue Engineering Group, Department of Histology, Faculty of Medicine, University of Granada, Granada, Spain., Quijano B; Andalusian Network for the Design and Translation of Advanced Therapies (And&tAT/RAdytTA) - Fundación Andaluza Progreso y Salud, MP. Junta de Andalucía, Seville, Spain., Aguilar E; Andalusian Network for the Design and Translation of Advanced Therapies (And&tAT/RAdytTA) - Fundación Andaluza Progreso y Salud, MP. Junta de Andalucía, Seville, Spain., Campos A; Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.; Tissue Engineering Group, Department of Histology, Faculty of Medicine, University of Granada, Granada, Spain., Carmona G; Andalusian Network for the Design and Translation of Advanced Therapies (And&tAT/RAdytTA) - Fundación Andaluza Progreso y Salud, MP. Junta de Andalucía, Seville, Spain malaminos@ugr.es gloria.carmona@juntadeandalucia.es., Alaminos M; Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain malaminos@ugr.es gloria.carmona@juntadeandalucia.es.; Tissue Engineering Group, Department of Histology, Faculty of Medicine, University of Granada, Granada, Spain.

Publikováno v: BMJ open [BMJ Open] 2024 Dec 05; Vol. 14 (12), pp. e093491. Date of Electronic Publication: 2024 Dec 05.