Using a bioengineered tissue to treat cleft palate in children
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
This study is testing a new bioengineered tissue to see if it can help children with cleft palate heal better than the usual surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 10 Months to 14 Months |
| Sex | All |
| Sponsor | Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental Academic / other |
| Locations | 1 site (Granada, Spain/Granada) |
| Trial ID | NCT06408337 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients diagnosed with total unilateral non-syndromic cleft lip and palate who are scheduled for surgical correction.
Not a fit: Patients with active infections, severe systemic disorders, or other congenital malformations may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance healing and reduce complications for children undergoing surgery for cleft palate.
How similar studies have performed: While this approach is innovative, similar studies using tissue engineering for cleft palate repair have shown promising results, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Granada, Spain/Granada
- University Hospital Virgen de las Nieves — Granada, Spain/Granada, Spain (Recruiting)
Study contacts
- Study coordinator: Elisa Cubiles
- Email: emontero@fibao.es
- Phone: 955048278
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.