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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

April 17, 2024

Primary Completion Date

April 17, 2028

Study Completion Date

December 17, 2028

Conditions
Cleft Lip and Palate
Interventions
PROCEDURE

implantation with an autologous human palatal mucosa substitute made of nanostructured fibrin-agarose generated by tissue engineering (BIOCLEFT).

cleft 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.

Trial Locations (1)

18014

RECRUITING

University Hospital Virgen de las Nieves, Granada

All Listed Sponsors
collaborator

Andalusian Network for Design and Translation of Advanced Therapies

OTHER

lead

Elisa María Cubiles Montero de Espinosa

OTHER