Safety and Efficacy of Bone Bioengineering Kit With Stem Cells for Alveolar Cleft Repair

Inclusion Criteria

• •Signed Informed Consent Form (ICF) from the legal guardian;
• •Signed Assent Form from the participant;
• •Patients aged 6 to 11 years at the time of the secondary bone graft surgery;
• •Participants diagnosed with unilateral cleft lip and palate of the pre-foramen incisive or transforamen type;
• •Patients must have had mesenchymal stem cells derived from deciduous teeth collected and stored in a biobank prior to signing the Informed Consent Form (ICF);
• •Patients with the maxilla previously aligned through orthodontic treatment and deemed suitable for the alveolar bone graft procedure;
• •Patients who are reliable and willing to be available throughout the study, attend all required study visits, and are willing and able to comply with study procedures as necessary.