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

Instituto de Tecnologia do Paraná

Status and phase

Begins enrollment in 4 months

Phase 3

Conditions

Cleft Lip Palate

Treatments

Combination Product: Bioengineering kit composed of stem cells from deciduous teeth and biomaterial.

Procedure: iliac crest bone graft surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT07305623

TECPAR_2025

Details and patient eligibility

About

The objective of this study is to compare the safety and efficacy of the bone tissue engineering kit-composed of 10⁶ mesenchymal stem cells derived from deciduous dental pulp combined with a collagen- and hydroxyapatite-based biomaterial-with secondary autogenous bone grafting for alveolar cleft closure in patients with cleft lip and palate.

Individuals aged 6 to 11 years with unilateral pre- and transforamen cleft lip and palate who have an indication for bone grafting will be included.

The study will be conducted in two stages. In Stage 1, patients will undergo surgery using only the bioengineering kit, and the primary outcome will be the average length of hospital stay after grafting with the engineering kit. In Stage 2, patients will be randomized to receive either the bioengineering kit treatment or the standard iliac crest bone graft surgery. In this stage, the primary outcome will be the success rate of the cleft lip and palate repair surgery, determined by the amount of bone formation in the alveolar cleft region, measured through volumetric analyses of computed tomography scans performed 12 months after grafting.

Enrollment

205 estimated patients

Sex

All

Ages

6 to 11 years old

Volunteers

No Healthy Volunteers

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.

Exclusion criteria

Previous surgery for alveolar cleft repair;
Presence of comorbidities (diabetes, cardiac conditions, hypertension) or allergies to latex gloves and suture materials (Catgut, Vicryl, Monocryl, Nylon, Polyester, or Polypropylene);
Presence of palatal fistulas resulting from previous surgeries;
Incomplete orthodontic or tomography documentation;
Eruption of the permanent canine prior to signing the Informed Consent Form (ICF) and Assent Form (AF), and prior to undergoing the secondary alveolar bone graft surgery;
Participants who are pregnant or breastfeeding at the time of screening or during the study.