Phase I-IIa, to Evaluate the Safety, Feasibility, and Efficacy of the Use of BIOCLEFT in the Treatment of Cleft Palate.
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Serious endocrine disorders/dysfunctions. * Malignant neoplasms * Active HIV, HBV or HCV infection. * Metabolic bone diseases (Paget's disease, hypercalcemia, etc.). * Children with cleft lip and palate who present other congenital malformations that, in the opinion of the researcher, could affe