Not Yet RecruitingPhase 3

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

Brazil205 participantsStarted 2026-07

Plain-language 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 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.

Who can participate

Age range

7 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Success rate of cleft lip and palate alveolar reconstruction surgery

Timeframe: 12 months

Trial details

NCT IDNCT07305623

SponsorInstituto de Tecnologia do Paraná

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

View on ClinicalTrials.gov More Cleft Lip Palate trials