Phase I-IIa, to Evaluate the Safety, Feasibility, and Efficacy of the Use of BIOCLEFT in the Treatment of Cleft Palate.

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 affect the result of the study or the interpretation of the results of the study. * Any other pathology that in the opinion of the investigator should not be included in the study for other medical or social reasons.