Phase I-IIa, Randomized, Controlled, Open-label, Single-center Clinical Trial to Evaluate Safety, Feasibility, and Efficacy of the Use of BIOCLEFT in the Treatment of Patients With Cleft Palate
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 10 months
Maximum Age: 1
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Spain
University Hospital Virgen de las Nieves
RECRUITING
Granada
Contact Information
Primary
Elisa Cubiles
emontero@fibao.es
955048278
Backup
Soraya Santana
ssantana@fibao.es
618 93 00 77
Time Frame
Start Date:2024-04-17
Estimated Completion Date:2028-12-17
Participants
Target number of participants:15
Treatments
Experimental: experimental
The experimental group will be implanted with an autologous human palatal mucosa substitute made of nanostructured fibrin-agarose generated by tissue engineering (BIOCLEFT). The implantation of this advanced therapy medication will cover the lateral defect generated by the mobilization of fibromucous flaps during standard surgery (uranostaphylorrhaphy
No_intervention: control group
These patients will be included in the control group and will receive the usual treatment for their disease (uranoestafilorrafia), without applying any type of restriction to the area used for the movement of the arms.