Phase I/II, controlled, open-label, randomized, single site clinical trial to assess the safety and feasibility, as well as hint efficacy evidence of a bioengineered palate mucosa substitute on nanostructured fibrin-agarose scaffolds with autologous mucosa tissue-specific cells (culture-expanded fibroblasts and keratinocytes), for tissue replacement and repair of donor area after the reconstruction of palate cleft defects (staphylorraphy), in comparison with standard care for donor mucosa.
Pediatric patients, of both sexes.
Diagnosis of total unilateral non-syndromic cleft lip and palate (FLPNS) that will undergo surgery for correction.
Children who have previously donated a sample of oral mucosa during the cleft lip repair procedure (cheiloplasty).
Informed consent signed by one or both parents (or legal guardian) adequately informed of the study and willing to follow the trial procedures and instructions.
Active infectious diseases.
Allergies or hypersensitivity to any of the components/excipients of the Investigational Product.
Severe hematological disorders/blood dyscrasias.
Severe hepatic or renal dysfunction/failure.
Elisa María Cubiles Montero de Espinosa
Lead sponsor
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Sponsor institution
Andalusian Network for Design and Translation of Advanced Therapies
Collaborator