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Study identifier: NCT06408337 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Cleft Lip and Palate  ·  Sponsor: Elisa María Cubiles Montero de Espinosa

PhasePhase 1/Phase 2
Planned participants15
Who can joinAll sexes, 10 Months to 14 Months
Healthy volunteersNo

About this study

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.

Talk to the study team

Elisa Cubiles  ·  955048278  ·  emontero@fibao.es

Soraya Santana  ·  618 93 00 77  ·  ssantana@fibao.es

Always discuss trial participation with your own doctor first.

Locations (1)

University Hospital Virgen de las NievesGranada, Spain/Granada, SpainRecruiting

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Source record: clinicaltrials.gov/study/NCT06408337