Status: Recruiting
Phase I-IIa, to Evaluate the Safety, Feasibility, and Efficacy of the Use of BIOCLEFT in the Treatment of Cleft Palate.
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.
Participants needed: 15
Trial details
Phase: Phase 1, Phase 2Age: 10-14Biological sex: AllType: InterventionalSponsor: Elisa María Cubiles Montero de EspinosaUpdated: May 10, 2024Locations: 1
Eligibility criteria
Pediatric patients, of both sexes. [+3]
Active infectious diseases. [+9]