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Phase I-IIa, randomized, controlled, open-label, single-center clinical trial to evaluate the safety, feasibility, and evidence of efficacy of the use of an autologous tissue-engineered nanostructured fibrin-agarose oral mucosa substitute for human palatal mucosa in the treatment of patients with cleft palate
EU CTIS ID: 2023-506913-23-00
What this study is testing
Evaluate the safety and feasibility of using an autologous tissue-engineered nanostructured fibrin-agarose human palatal mucosa substitute in the treatment of cleft palate
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Paediatric patients of either sex. 2. Diagnosis of non-syndromic total unilateral cleft lip and palate (FLPNS) who are going to undergo surgery for correction. 3. Children who have previously donated an oral mucosa sample during the cleft lip repair procedure (cheiloplasty). 4. 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 likely can't join if
- 5. Active infectious diseases. 6. Allergies or hypersensitivity to any of the components/excipients of the investigational product. 7. Haematological disorders/severe blood dyscrasias. 8. Severe hepatic or renal dysfunction/insufficiency. 9. Severe endocrine disorders/dysfunction. 10. Malignant neoplasms. 11. Active HIV, HBV or HCV infection. 12. Metabolic bone diseases (Paget's disease, hypercalcaemia, etc.). 13. Children with cleft lip and palate who have other congenital malformations which, in the opinion of the investigator, could affect the outcome of the study or the interpretation of the study results. 14. 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.
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.