Back to resultsBone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair (CLOSE)
Primary Purpose
Cleft Lip and Palate
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Mesenchymal stem cells associated with biomaterials
Iliac crest autogenous bone graft
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Lip and Palate
Eligibility Criteria
Inclusion Criteria:
- non syndromic unilateral cleft lip and palate;
- age between 7 and 12 years;
- to have the jaw aligned and ready to receive the graft.
Exclusion Criteria:
- previous surgery to correct the alveolar cleft;
- have the canine erupted before grafting;
- incomplete orthodontic treatment;
- incomplete CT scan documentation.
Sites / Locations
- Hospital Sírio-Libanes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mesenchymal stem cells associated with biomaterials
Iliac crest autogenous bone graft
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Alveolar bone filling rate
Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area.
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.
Secondary Outcome Measures
Non serious adverse events
Frequency of participants experiencing at least one non serious adverse event
Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair
Position of the canine tooth and formation of dental root
Position of the canine tooth and formation of dental root assessed by CT scan
Alveolar bone filling rate
Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area.
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.
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)
Full Information
NCT ID
NCT03766217
First Posted
November 29, 2018
Last Updated
May 11, 2020
Sponsor
Hospital Sirio-Libanes
Collaborators
Ministry of Health, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT03766217
Brief Title
Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair
Acronym
CLOSE
Official Title
Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 5, 2019 (Actual)
Primary Completion Date
December 6, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Sirio-Libanes
Collaborators
Ministry of Health, Brazil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip and Palate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mesenchymal stem cells associated with biomaterials
Arm Type
Experimental
Arm Description
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).
Arm Title
Iliac crest autogenous bone graft
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Mesenchymal stem cells associated with biomaterials
Intervention Description
Deciduous dental pulp mesenchymal stem cells associated with hydroxyapatita/collagen.
Intervention Type
Combination Product
Intervention Name(s)
Iliac crest autogenous bone graft
Intervention Description
Autogenous bone will be obtained from iliac crest.
Primary Outcome Measure Information:
Title
Alveolar bone filling rate
Description
Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area.
Time Frame
12 months
Title
Serious adverse events
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Non serious adverse events
Description
Frequency of participants experiencing at least one non serious adverse event
Time Frame
15 days; 3, 6 and 12 months
Title
Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair
Time Frame
Bone tissue engineering
Title
Position of the canine tooth and formation of dental root
Description
Position of the canine tooth and formation of dental root assessed by CT scan
Time Frame
12 months
Title
Alveolar bone filling rate
Description
Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area.
Time Frame
6 months
Title
Serious adverse events
Description
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.
Time Frame
15 days; 3 and 6 months
Title
Patient-reported outcome (PRO, including appearance, fuction and quality of life)
Description
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)
Time Frame
pre surgery and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
non syndromic unilateral cleft lip and palate;
age between 7 and 12 years;
to have the jaw aligned and ready to receive the graft.
Exclusion Criteria:
previous surgery to correct the alveolar cleft;
have the canine erupted before grafting;
incomplete orthodontic treatment;
incomplete CT scan documentation.
Facility Information:
Facility Name
Hospital Sírio-Libanes
City
São Paulo
ZIP/Postal Code
01308-050
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
32256610
Citation
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.
Results Reference
background
PubMed Identifier
31781247
Citation
Pinheiro 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.
Results Reference
background
Links:
URL
https://www.hindawi.com/journals/sci/2020/6234167
Description
First results published
URL
https://www.hindawi.com/journals/sci/2019/7951696/
Description
"in vitro" results
Learn more about this trial
Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair
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