Repairing Cleft Palate with Dental Pulp Stem Cells (DPSCs)
ABSTRACT
Safety and Efficacy of Bone Bioengineering Kit With Stem Cells for Alveolar Cleft Repair
ClinicalTrials.gov Identifier: NCT07305623
Study information
Sponsor: Instituto de Tecnologia do Paraná (TECPAR)
Responsible Party: Daniela Franco Bueno, Instituto de Tecnologia do Paraná
Study Phase: Phase II
Study Type: Interventional (Randomized)
Estimated Enrollment: 52 participants
Study Population: Children with unilateral cleft lip and palate requiring secondary alveolar bone grafting.
BACKGROUND:Children born with cleft lip and palate often require secondary alveolar bone grafting to repair the gap in the upper jaw and provide support for tooth eruption and facial development.The current standard treatment involves harvesting bone from the patient's iliac crest, which can lead to postoperative pain, donor-site complications, and extended recovery. Researchers are investigating whether dental pulp stem cells can regenerate alveolar bone while eliminating the need for autologous bone harvesting.
METHODS: This Phase II randomized clinical trial evaluates a bone bioengineering kit containing 1 × 10⁶ mesenchymal stem cells derived from cryopreserved deciduous dental pulp combined with an osteoconductive collagen-hydroxyapatite scaffold.Participants are randomly assigned to receive either the stem cell-based bioengineering kit or the conventional iliac crest bone graft. Bone regeneration will be assessed using three-dimensional computed tomography, volumetric bone measurements, clinical healing, and safety evaluations during postoperative follow-up.
RESULTS: The study is currently recruiting participants, and final clinical outcomes have not yet been reported. Researchers will compare bone formation, bone volume, graft integration, postoperative recovery, and adverse events between the stem cell-treated group and the conventional bone graft group to determine whether the bioengineered approach provides comparable or superior clinical outcomes.
CONCLUSIONS: This Phase II clinical trial is evaluating whether deciduous dental pulp stem cells can provide a safe and effective alternative to conventional bone grafting for alveolar cleft repair.If successful, this regenerative approach could reduce surgical morbidity while advancing stem cell-based therapies for children with cleft lip and palate.
ClinicalTrials.gov Identifier: NCT07305623
Sponsor: Instituto de Tecnologia do Paraná (TECPAR)
Responsible Party: Daniela Franco Bueno, Instituto de Tecnologia do Paraná