Study on the Safety and Feasibility of Using Autologous Oral Mucosa-Derived Keratinocytes and Fibroblasts for Treating Cleft Palate Patients
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying a condition known as cleft palate, which is a gap or opening in the roof of the mouth that occurs when the tissue doesn't fuse together during pregnancy. The trial is testing a new treatment called BIOCLEFT, which is a special type of tissue made from a patient's own cells. This tissue is created using cells from the inside of the mouth, known as oral mucosa, and is grown outside the body in a lab. The cells used are keratinocytes and fibroblasts, which are important for skin and tissue repair. These cells are expanded, meaning they are grown in larger numbers, and then placed in a supportive structure made of fibrin-agarose, which helps them form a living tissue equivalent.
The purpose of the study is to evaluate the safety and feasibility of using this new tissue to treat patients with cleft palate. Participants in the study will receive either the BIOCLEFT treatment or a standard treatment, and the study will compare the outcomes. The trial will monitor how well the new tissue works in terms of healing and improving the appearance of the palate, as well as its impact on growth, hearing, speech, and overall quality of life. The study will also look at any side effects or adverse events that may occur during the treatment process.
The study is designed to be conducted in phases, starting with a small group of patients to ensure the treatment can be safely implanted and is effective. The trial will continue to gather information over time to determine the best ways to use this new treatment for cleft palate. Participants will be closely monitored throughout the study to ensure their safety and to gather valuable data on the treatment's effectiveness.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- Children of any gender can participate.
- The child must have a diagnosis of a non-syndromic total unilateral cleft lip and palate. This means the cleft affects one side of the lip and palate and is not part of a larger syndrome.
- The child must be scheduled for surgery to correct the cleft lip and palate.
- The child must have previously given a sample of their mouth lining (oral mucosa) during a previous surgery to repair the cleft lip, known as cheiloplasty.
- One or both parents, or a legal guardian, must sign an informed consent form. This means they understand the study and agree to follow the study's procedures and instructions.
Who cannot join the trial?
10 criteria
- Patients with any other serious health conditions that could interfere with the study.
- Patients who are unable to follow the study procedures or instructions.
- Patients who have participated in another clinical trial recently.
- Patients who are allergic to any materials used in the study.
- Patients who are pregnant or breastfeeding.
- Patients who have a history of poor wound healing.
- Patients who have an active infection at the time of the study.
- Patients who are taking medications that could affect the study results.
- Patients who have a history of drug or alcohol abuse.
- Patients who have a condition that affects their immune system.
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