Condition: Cleft Lip and Palate · Sponsor: Elisa María Cubiles Montero de Espinosa
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.
This description comes directly from the study's public registry record.
Elisa Cubiles · 955048278 · emontero@fibao.es
Soraya Santana · 618 93 00 77 · ssantana@fibao.es
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| University Hospital Virgen de las Nieves | Granada, Spain/Granada, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06408337