Using a bioengineered tissue to treat cleft palate in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety, feasibility, and efficacy of BIOCLEFT, a bioengineered palatal mucosa substitute, in pediatric patients with total unilateral non-syndromic cleft lip and palate. The trial consists of two phases: an initial non-randomized phase involving 5 patients followed by a randomized phase with an additional 10 patients. Participants will receive either the investigational treatment or standard surgical reconstruction, with follow-up assessments conducted over 24 months to monitor outcomes. The study aims to determine if this innovative approach can improve tissue repair and patient recovery compared to standard care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• University Hospital Virgen de las Nieves
  Granada, Spain/Granada, Spain Recruiting

Study contacts

• Study coordinator: Elisa Cubiles
• Email: emontero@fibao.es
• Phone: 955048278

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.