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.
Parallel
implantation with an autologous human palatal mucosa substitute made of nanostructured fibrin-agarose generated by tissue engineering (BIOCLEFT).
Procedure/Surgerycleft palate repair surgery, all patients in the study will receive the standard treatment (uranostaphyllorrhaphy), with the only difference that patients assigned to the experimental study group will additionally have BIOCLEFT tissue obtained through tissue engineering grafted onto them. the lateral area of the palatine bone exposed when mobilizing the flaps. For the implant, the BIOCLEFT fabric will be placed in the area of exposed bone, sized to the size of the defect and sutured using uncoated, monofilament long-term absorbable synthetic suture.
Evaluate implant´s feasibility and appearance of adverse events and serious adverse events related to treatment
Incidence of Serious Adverse Events after at the time of the implant of study drug.
Evaluation of the time of the regeneration and healing of the lateral defect of the palatine bone from the moment of the intervention
Evaluation of the aesthetic result through analysis of photographs
A scale designed ad hoc for the present trial will be used (aesthetic appearance assessment scale)
Preliminary evaluation of craniofacial growth through analysis of craniofacial photographs
Hearing evaluation
Otoscopic/otomicroscopic examination and tympanogram by the otorhinolaryngologist, and placement of aeration tubes if considered necessary. The need or not to perform follow-up during the trial visits will be assessed depending on whether or not the patient presents any type of pathology.
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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
