NCT07305623

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

Phase III Randomized Clinical Trial on the Use of a Bone Bioengineering Kit With Stem Cells Versus Autogenous Iliac Crest Graft for Alveolar Cleft Repair in Patients With Cleft Lip and Palate

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 205 (estimated)
• Sponsor: Instituto de Tecnologia do Paraná · Academic / Other
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cleft Lip Palate

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Bioengineering kit composed of stem cells from deciduous teeth and biomaterial.	Bone tissue engineering kit composed of 10⁶ mesenchymal stromal cells/mesenchymal stem cells (MSCs) derived from dental pulp, combined with a biomaterial consisting of hydroxyapatite and collagen (BioOss Collagen, 250 mg, Geistlich).
PROCEDURE	iliac crest bone graft surgery	standard iliac crest bone graft surgery

Timeline

• Start date: 2026-07-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-12-26
• Last updated: 2025-12-26

Locations

1 site across 1 country: Brazil