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

NCT07305623 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: TECPAR_2025
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

bioengineering kit; Stem cells

Outcome Measures

Primary Outcomes (1)

• Success rate of the cleft lip and palate repair surgery

  average amount of bone formation in the alveolar cleft region, measured through volumetric analyses of computed tomography scans

  12 months

Study Arms (2)

bioengineering kit

EXPERIMENTAL

Patients will receive the bioengineering kit composed of stem cells from deciduous teeth and biomaterial.

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

Iliac crest bone graft

ACTIVE COMPARATOR

Standard iliac crest bone graft surgery

Procedure: iliac crest bone graft surgery

Interventions

Bioengineering kit composed of stem cells from deciduous teeth and biomaterial. COMBINATION_PRODUCT

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).

bioengineering kit

iliac crest bone graft surgery PROCEDURE

standard iliac crest bone graft surgery

Iliac crest bone graft

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Tecnologia do Paraná: lead

Study Sites (1)

Hospital Pequeno Príncipe

Curitiba, Paraná, Brazil

Location

MeSH Terms

Interventions

Biocompatible Materials

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD

Model Details: Patients will receive the bioengineering kit composed of stem cells from deciduous teeth and biomaterial.

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 26, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)