Cleft Lip and PalatePhase 3CLOSENCT03766217
Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair
A Phase 3 study testing Mesenchymal stem cells associated with biomaterials and Iliac crest autogenous bone graft in people with Cleft Lip and Palate, run by Hospital Sirio-Libanes at 1 site in Brazil.
Trial summary
Iliac crest autogenous bone graft is accepted as the most effective method for secondary alveolar cleft repair. However this method is associated with complications. As an alternative, mesenchymal stem cells associated with biomaterials have been used for the rehabilitation of the alveolar bone cleft of patients with… Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Mesenchymal stem cells associated with biomaterials and Iliac crest autogenous bone graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Apr 2019to 15 Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child
Who may be able to join
- non syndromic unilateral cleft lip and palate;
- age between 7 and 12 years;
- to have the jaw aligned and ready to receive the graft.
Who cannot join
- previous surgery to correct the alveolar cleft;
- have the canine erupted before grafting;
- incomplete orthodontic treatment;
- incomplete CT scan documentation.
Trial locations and contacts
1 site in 1 country.
About this study
Iliac crest autogenous bone graft is accepted as the most effective method for secondary alveolar cleft repair. However this method is associated with complications. As an alternative, mesenchymal stem cells associated with biomaterials have been used for the rehabilitation of the alveolar bone cleft of patients with cleft lip and palate. This is a RCT comparing mesenchymal stem cells obtained from autogenous deciduous dental pulp associated with biomaterials versus iliac crest autogenous bone graft for secondary alveolar cleft repair.
- Conditions
- Cleft Lip and Palate
- Being tested
- Mesenchymal stem cells associated with biomaterials, Iliac crest autogenous bone graft
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cells associated with biomaterialsCombination product
Deciduous dental pulp mesenchymal stem cells associated with hydroxyapatita/collagen.
Iliac crest autogenous bone graftCombination product
Autogenous bone will be obtained from iliac crest.
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cells associated with biomaterials | Experimental | Mesenchymal stem cells obtained from autogenous deciduous dental pulp associated with biomaterials. The stem cells will be obtained by enzimatic digestion in GMP laboratory and will be seed into the biomaterial (hydroxyapatite/collagen). Receives: Combination Product: Mesenchymal stem cells associated with biomaterials |
| Iliac crest autogenous bone graft | Active comparator | Autogenous bone will be obtained from iliac crest. The prepare of the receptor area will be the same in both arms and will follow current recommendations. Receives: Combination Product: Iliac crest autogenous bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar bone filling rate
Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area.
Measured: 12 months
Serious adverse events
Serious adverse events resulting in death, life-threatening event, hospitalization, prolongation of existing hospitalization (for > 24 hours), persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. Important medical event that may not result in death, be life threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon medical judgment, it may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Frequency of participants experiencing at least one serious adverse event.
Measured: 12 months
Secondary outcomes (6)
Non serious adverse events
Frequency of participants experiencing at least one non serious adverse event
Measured: 15 days; 3, 6 and 12 months
Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair
Measured: Bone tissue engineering
Position of the canine tooth and formation of dental root
Position of the canine tooth and formation of dental root assessed by CT scan
Measured: 12 months
Alveolar bone filling rate
Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area.
Measured: 6 months
Serious adverse events
Serious adverse events resulting in death, life-threatening event, hospitalization, prolongation of existing hospitalization (for > 24 hours), persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. Important medical event that may not result in death, be life threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon medical judgment, it may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Frequency of participants experiencing at least one serious adverse event.
Measured: 15 days; 3 and 6 months
Patient-reported outcome (PRO, including appearance, fuction and quality of life)
Assessed by CLEFT-Q, a self-report PRO instrument, tool answered independently patients themselves, without interpretation by the parent(s) or healthcare provider. The CLEFT-Q consists of 13 independently functioning domains (171 items) measuring appearance, facial function and quality of life. Each domain is composed of a series of items that together evaluate a unidimensional construct. A higher score means a better result (continuous outcome, measured by: mean)
Measured: pre surgery and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start5 Apr 2019
- Primary completion6 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cleft Lip and 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Principal investigator, Daniela Franco Bueno, Hospital Sirio-Libanes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766217
- Sponsor's protocol ID
- CAAE47719215.5.0000.5461
- Acronym
- CLOSE
- Status last verified
- May 2020
- First submitted
- 29 Nov 2018
- Last updated
- 13 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tanikawa DYS, Pinheiro CCG, Almeida MCA, Oliveira CRGCM, Coudry RA, Rocha DL, Bueno DF. Deciduous Dental Pulp Stem Cells for Maxillary Alveolar Reconstruction in Cleft Lip and Palate Patients. Stem Cells Int. 2020 Mar 12;2020:6234167. doi: 10.1155/2020/6234167. eCollection 2020.
PubMed 32256610Pinheiro CCG, Leyendecker Junior A, Tanikawa DYS, Ferreira JRM, Jarrahy R, Bueno DF. Is There a Noninvasive Source of MSCs Isolated with GMP Methods with Better Osteogenic Potential? Stem Cells Int. 2019 Nov 6;2019:7951696. doi: 10.1155/2019/7951696. eCollection 2019.
PubMed 31781247
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair
- ClinicalTrials.gov ID
- NCT03766217
- Acronym / sponsor ID
- CLOSE / CAAE47719215.5.0000.5461
- Conditions
- Cleft Lip and Palate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Iliac crest autogenous bone graft is accepted as the most effective method for secondary alveolar cleft repair. However this method is associated with complications. As an alternative, mesenchymal stem cells associated with biomaterials have been used for the rehabilitation of the alveolar bone cleft of patients with cleft lip and palate. This is a RCT comparing mesenchymal stem cells obtained from autogenous deciduous dental pulp associated with biomaterials versus iliac crest autogenous bone graft for secondary alveolar cleft repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cells associated with biomaterials | Experimental | Combination Product: Mesenchymal stem cells associated with biomaterialsMesenchymal stem cells obtained from autogenous deciduous dental pulp associated with biomaterials. The stem cells will be obtained by enzimatic digestion in GMP laboratory and will be seed into the biomaterial (hydroxyapatite/collagen). |
| Iliac crest autogenous bone graft | Active comparator | Combination Product: Iliac crest autogenous bone graftAutogenous bone will be obtained from iliac crest. The prepare of the receptor area will be the same in both arms and will follow current recommendations. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- non syndromic unilateral cleft lip and palate;
- age between 7 and 12 years;
- to have the jaw aligned and ready to receive the graft.
Key exclusion criteria (4 listed)
- previous surgery to correct the alveolar cleft;
- have the canine erupted before grafting;
- incomplete orthodontic treatment;
- incomplete CT scan documentation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal stem cells associated with biomaterialsDeciduous dental pulp mesenchymal stem cells associated with hydroxyapatita/collagen. | Combination product | Mesenchymal stem cells associated with biomaterials |
| Iliac crest autogenous bone graftAutogenous bone will be obtained from iliac crest. | Combination product | Iliac crest autogenous bone graft |
Primary outcome
Alveolar bone filling rate
Time frame: 12 months
Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area.
Serious adverse events
Time frame: 12 months
Serious adverse events resulting in death, life-threatening event, hospitalization, prolongation of existing hospitalization (for > 24 hours), persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. Important medical event that may not result in death, be life threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon medical judgment, it may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Frequency of participants experiencing at least one serious adverse event.
6 secondary outcomes
Non serious adverse events
Time frame: 15 days; 3, 6 and 12 months
Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair
Time frame: Bone tissue engineering
Position of the canine tooth and formation of dental root
Time frame: 12 months
Alveolar bone filling rate
Time frame: 6 months
Serious adverse events
Time frame: 15 days; 3 and 6 months
Patient-reported outcome (PRO, including appearance, fuction and quality of life)
Time frame: pre surgery and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Background: PubMed 32256610Tanikawa DYS, Pinheiro CCG, Almeida MCA, Oliveira CRGCM, Coudry RA, Rocha DL, Bueno DF. Deciduous Dental Pulp Stem Cells for Maxillary Alveolar Reconstruction in Cleft Lip and Palate Patients. Stem Cells Int. 2020 Mar 12;2020:6234167. doi: 10.1155/2020/6234167. eCollection 2020.
- Background: PubMed 31781247Pinheiro CCG, Leyendecker Junior A, Tanikawa DYS, Ferreira JRM, Jarrahy R, Bueno DF. Is There a Noninvasive Source of MSCs Isolated with GMP Methods with Better Osteogenic Potential? Stem Cells Int. 2019 Nov 6;2019:7951696. doi: 10.1155/2019/7951696. eCollection 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mesenchymal stem cells associated with biomaterials and Iliac crest autogenous bone graft in people with Cleft Lip and Palate, run by Hospital Sirio-Libanes at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alveolar bone filling rate (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03766217, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.