Cleft lip and palate Trials in Disease

Study on the Safety and Feasibility of Using Autologous Oral Mucosa-Derived Keratinocytes and Fibroblasts for Treating Cleft Palate Patients

This clinical trial is testing a groundbreaking treatment approach called BIOCLEFT, which uses tissue grown from a patient's own cells to help repair the roof of the mouth in children with cleft palate. The treatment involves taking a small sample of tissue from the inside of the child's mouth (oral mucosa) during an earlier lip repair surgery, growing specific cells from this sample in a laboratory, and then creating a living tissue substitute that can be implanted during palate repair surgery.

Who can participate:

• Children of any gender with a diagnosis of non-syndromic total unilateral cleft lip and palate (meaning the cleft affects one side and is not part of a larger syndrome)
• Children scheduled for surgery to correct the cleft lip and palate
• Children who previously provided an oral mucosa sample during cleft lip repair surgery
• One or both parents or a legal guardian must sign an informed consent form and agree to follow the study procedures

Who cannot participate:

• Patients with other serious health conditions that could interfere with the study
• Patients unable to follow study procedures or instructions
• Patients who recently participated in another clinical trial
• Patients with allergies to materials used in the study
• Patients with a history of poor wound healing
• Patients with an active infection at the time of the study
• Patients taking medications that could affect study results
• Patients with a history of drug or alcohol abuse
• Patients with conditions affecting their immune system

Main focus and goal:

The primary goal of this trial is to evaluate whether using tissue grown from a patient's own cells is safe and practical for treating cleft palate. The study follows a careful process: first, cells called keratinocytes and fibroblasts are grown from the oral mucosa sample in a laboratory. These cells are then placed in a supportive structure made of fibrin-agarose to create a living tissue equivalent. This engineered tissue is surgically implanted into the palatal area during the cleft repair procedure.

Researchers will closely monitor participants after surgery to track any side effects and assess how well the new tissue works. They will examine healing progress, aesthetic appearance, craniofacial growth, hearing, speech development, and overall quality of life. The study is designed in phases, starting with a small group of patients to ensure the treatment is safe and effective. Follow-up evaluations will continue until November 2027 to gather comprehensive long-term data.

Investigational treatment:

The treatment being tested is called Autologous Tissue-Engineered Nanostructured Fibrin-Agarose Oral Mucosa Substitute. This specially designed tissue substitute is created entirely from the patient's own cells, which reduces the risk of rejection. The fibrin-agarose structure provides support while the keratinocytes and fibroblasts work to integrate with the patient's existing tissue and promote natural healing and tissue regeneration. This approach represents a significant advancement in regenerative medicine for cleft palate repair.