Cleft Lip PalatePhase 3NCT07305623
Safety and Efficacy of Bone Bioengineering Kit With Stem Cells for Alveolar Cleft Repair
A Phase 3 study testing Bioengineering kit composed of stem cells from deciduous teeth and biomaterial. and iliac crest bone graft surgery in people with Cleft Lip Palate, run by Instituto de Tecnologia do Paraná at 2 sites in Brazil.
Trial summary
The objective of this study is to compare the safety and efficacy of a bone tissue engineering kit - composed of 10⁶ autologous mesenchymal stem cells derived from deciduous dental pulp combined with Bio-Oss® Collagen - with secondary autogenous iliac crest bone grafting for alveolar cleft reconstruction in patients… Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Cleft Lip Palate
- What is being tested?
- Bioengineering kit composed of stem cells from deciduous teeth and biomaterial. and iliac crest bone graft surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 2 sitesBrazil
- Study dates
- Jul 2026to Dec 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written Informed Consent Form (ICF) signed by the participant's legally authorized representative.
- Written Assent Form signed by the participant.
- Patients aged 7 to 12 years at the time of secondary alveolar bone graft surgery.
- Patients diagnosed with unilateral pre-foramen or transforamen cleft lip and palate.
- Availability of autologous mesenchymal stem cells derived from deciduous dental pulp, previously stored in a biobank before signing the Informed Consent Form (ICF).
- Patients with a maxillary arch previously aligned through orthodontic treatment and considered suitable for alveolar bone grafting.
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- Medically fit to undergo the surgical procedure, as determined by the responsible clinical team.
- Complete and up-to-date vaccination schedule according to the Brazilian National Immunization Program (PNI).
- Participants and their legal representatives are considered reliable, willing to comply with the study procedures, attend all required study visits, and remain available throughout the study period.
Who cannot join
- Previous surgery for alveolar cleft repair.
- Known allergy to latex gloves or suture materials (Catgut, Vicryl, Monocryl, Nylon, Polyester, or Polypropylene).
- Uncontrolled systemic diseases or other clinical conditions that may increase surgical risk or interfere with bone healing, including, but not limited to, uncontrolled diabetes mellitus, clinically significant cardiovascular disease, or other conditions deemed relevant by the investigator.
- Metabolic bone diseases or other conditions that may impair bone formation or healing.
- Congenital or acquired immunosuppression, or use of immunosuppressive medications that may interfere with healing or treatment response.
- History of radiotherapy or chemotherapy involving the head and neck region, when applicable, or any other condition that may compromise bone repair.
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- Presence of palatal fistulas resulting from previous surgeries.
- Incomplete orthodontic or computed tomography documentation.
- Eruption of the permanent canine before signing the Informed Consent Form (ICF) and Assent Form, and before secondary alveolar bone graft surgery.
- Participants who are pregnant or breastfeeding at the time of screening or during the study.
- Presence of systemic infection, active infection of the oral cavity or surgical site, or any infectious condition that, in the investigator's opinion, may compromise participant safety or the study outcomes.
- Inability to obtain or release the investigational product due to failure in cell processing or failure to meet the established quality control criteria.
- Concurrent participation in another interventional clinical trial or previous participation in a study that, in the investigator's judgment, may interfere with the results of the present study.
- Any other condition that, in the opinion of the investigator or designee, may preclude informed consent, pose an unacceptable risk to the participant, compromise protocol compliance, interfere with endpoint assessment, or otherwise jeopardize the objectives of the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites
Hospital Infantil Dr. Jeser Amarante Faria
Joinville, Santa Catarina
Gustavo Lara Achôa, DDS, +55 (47) 3145-1600, gustavo.achoa@unisociesc.com.br
Gustavo Lara Achôa, DDS
Hospitais Universitários da Universidade Estadual de Ponta Grossa (HU-UEPG)
Ponta Grossa, Paraná
Fábio André dos Santos, DDS, +55 (42) 3219-8888, fasantos@uepg.br
Fábio André dos Santos, DDS
About this study
Official title: 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
The objective of this study is to compare the safety and efficacy of a bone tissue engineering kit - composed of 10⁶ autologous mesenchymal stem cells derived from deciduous dental pulp combined with Bio-Oss® Collagen - with secondary autogenous iliac crest bone grafting for alveolar cleft reconstruction in patients with cleft lip and palate.
Individuals aged 7 to 12 years with unilateral pre-foramen or transforamen cleft lip and palate who require secondary alveolar bone grafting and have previously cryopreserved autologous deciduous dental pulp-derived mesenchymal stem cells will be eligible for inclusion.
The study will be conducted in two stages. Stage 1 is a prospective, single-arm study designed to evaluate the initial safety of the investigational product, with primary endpoints consisting of the incidence of procedure-related adverse events and postoperative pain until hospital discharge. Stage 2 is a prospective, randomized, assessor-blinded clinical trial comparing the bone tissue engineering kit with standard autogenous iliac crest bone grafting. The co-primary endpoints are the success rate of alveolar reconstruction, defined as ≥70% bone fill of the alveolar cleft measured by volumetric computed tomography 12 months after surgery, and the incidence of procedure-related adverse events.
- Conditions
- Cleft Lip Palate
- Being tested
- Bioengineering kit composed of stem cells from deciduous teeth and biomaterial., iliac crest bone graft surgery
- Keywords
- bioengineering kit, Stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
iliac crest bone graft surgeryProcedure or surgery
standard iliac crest bone graft surgery
| Study group | Role | What they receive |
|---|---|---|
| bioengineering kit | Experimental | Patients will receive the bioengineering kit composed of stem cells from deciduous teeth and biomaterial. Receives: 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 Receives: Procedure: iliac crest bone graft surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of cleft lip and palate alveolar reconstruction surgery
Proportion of participants achieving successful alveolar reconstruction, defined as ≥70% filling of the alveolar cleft with newly formed bone, assessed by volumetric analysis of computed tomography scans.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study startJul 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip PalateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will receive the bioengineering kit composed of stem cells from deciduous teeth and biomaterial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Tecnologia do Paraná
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Franco Bueno, Instituto de Tecnologia do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305623
- Sponsor's protocol ID
- TECPAR_2025
- Status last verified
- Jul 2026
- First submitted
- 12 Dec 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No