RecruitingPhase 1Phase 2NCT06408337

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

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

Sponsor

Elisa María Cubiles Montero de Espinosa

Enrollment

15 participants

Start Date

Apr 17, 2024

Study Type

INTERVENTIONAL

Conditions

Cleft Lip and Palate

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

Min Age: 10 MonthsMax Age: 14 Months

Inclusion Criteria4

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.

Exclusion Criteria10

Active infectious diseases.
Allergies or hypersensitivity to any of the components/excipients of the Investigational Product.
Severe hematological disorders/blood dyscrasias.
Severe hepatic or renal dysfunction/failure.
Serious endocrine disorders/dysfunctions.
Malignant neoplasms
Active HIV, HBV or HCV infection.
Metabolic bone diseases (Paget's disease, hypercalcemia, etc.).
Children with cleft lip and palate who present other congenital malformations that, in the opinion of the researcher, could affect the result of the study or the interpretation of the results of the study.
Any other pathology that in the opinion of the investigator should not be included in the study for other medical or social reasons.

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Interventions

PROCEDUREimplantation 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.