Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair

Cleft Lip and Palate Clinical Trial

— CLOSE  

Official title:

Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03766217
• Other study ID #: CAAE47719215.5.0000.5461
• Status: Completed
• Phase: Phase 3
• Start date: April 5, 2019
• Est. completion date: December 15, 2019

Study information

• Verified date: May 2020
• Source: Hospital Sirio-Libanes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 15, 2019
• Est. primary completion date: December 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

Combination Product:
• Mesenchymal stem cells associated with biomaterials
Deciduous dental pulp mesenchymal stem cells associated with hydroxyapatita/collagen.
• Iliac crest autogenous bone graft
Autogenous bone will be obtained from iliac crest.

Locations

Country	Name	City	State
Brazil	Hospital Sírio-Libanes	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Sirio-Libanes	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alveolar bone filling rate	Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area.	12 months
Primary	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.	12 months
Secondary	Non serious adverse events	Frequency of participants experiencing at least one non serious adverse event	15 days; 3, 6 and 12 months
Secondary	Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair		Bone tissue engineering
Secondary	Position of the canine tooth and formation of dental root	Position of the canine tooth and formation of dental root assessed by CT scan	12 months
Secondary	Alveolar bone filling rate	Alveolar bone filling rate defined by the filling of at least 70% of the alveolar cleft area.	6 months
Secondary	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.	15 days; 3 and 6 months
Secondary	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)	pre surgery and 12 months

External Links

•   "in vitro" results
•   First results published