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.