Actively Recruiting
Phase I-IIa, to Evaluate the Safety, Feasibility, and Efficacy of the Use of BIOCLEFT in the Treatment of Cleft Palate.
Led by Elisa María Cubiles Montero de Espinosa · Updated on 2024-05-10
15
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
Sponsors
E
Elisa María Cubiles Montero de Espinosa
Lead Sponsor
A
Andalusian Network for Design and Translation of Advanced Therapies
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase I-IIa, to Evaluate the Safety, Feasibility, and Efficacy of the Use of BIOCLEFT in the Treatment of Cleft Palate.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients of both sexes
- Diagnosis of total unilateral non-syndromic cleft lip and palate requiring surgical correction
- Children who previously donated oral mucosa during cleft lip repair surgery
- Signed informed consent by one or both parents or legal guardians willing to follow study procedures
You will not qualify if you...
- Presence of active infectious diseases
- Allergies or hypersensitivity to any component of the investigational product
- Severe blood disorders or dyscrasias
- Severe liver or kidney dysfunction or failure
- Serious endocrine disorders
- Malignant neoplasms
- Active HIV, HBV, or HCV infection
- Metabolic bone diseases such as Paget's disease or hypercalcemia
- Presence of other congenital malformations that may affect study results
- Any other medical or social condition deemed exclusionary by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital Virgen de las Nieves
Granada, Spain/Granada, Spain, 18014
Actively Recruiting
Research Team
E
Elisa Cubiles
CONTACT
S
Soraya Santana
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here