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

Recruiting now · Phase 1/Phase 2

Conditions studied: Cleft Lip and Palate

In brief

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.

Key facts

Study ID

NCT06408337

Run by

Elisa María Cubiles Montero de Espinosa

People needed

15

Starts

2024-04-17

Expected to finish

2028-12-17

Last updated by the study team

2024-05-10

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University Hospital Virgen de las Nieves — Granada, Spain/Granada, Spain (enrolling)

Full record on ClinicalTrials.gov

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