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Tests treatment safety and results for Cleft Lip and Palate
Official title Phase I-IIa, to Evaluate the Safety, Feasibility, and Efficacy of the Use of BIOCLEFT in the Treatment of Cleft Palate.
ClinicalTrials.gov ID: NCT06408337
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 14
You may be able to join 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...
You likely can't join 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
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Granada, Spain/Granada, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 months to 14 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Granada, Spain/Granada, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.