Phase I-IIa, to Evaluate the Safety, Feasibility, and Efficacy of the Use of BIOCLEFT in the Treatment of Cleft Palate.

Launched by ELISA MARÍA CUBILES MONTERO DE ESPINOSA · May 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BIOCLEFT for children with a condition known as cleft lip and palate. The goal is to see if BIOCLEFT is safe and effective in helping repair the mouth after surgery, compared to the usual treatment options. This new treatment uses a special material combined with the patient’s own cells to help heal the area where tissue was taken for the surgery.

To join the trial, children must be between 3 and 12 years old and have a specific type of cleft lip and palate that requires surgery. They also need to have previously provided a small sample of tissue during an earlier surgery. Participants will be closely monitored throughout the study, and parents or guardians will need to provide consent and follow the trial requirements. It’s important to know that children with certain health conditions, like infections or severe illnesses, may not be eligible to participate. This trial is currently recruiting participants, so interested families should reach out for more information.

Gender

ALL

Eligibility 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.