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Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients

Primary Purpose

Cleft Lip and Palate

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
maxillary alveolar graft by tissue engineering
Bone tissue engineering using mesenchymal stem cells
Sponsored by
Hospital Sirio-Libanes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Lip and Palate focused on measuring Cleft lip and palate, Deciduous dental pulp stem cells, mesenchymal stem cells, tissue engineering, bone tissue engineering, bioengineering

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of unilateral cleft lip and palate ;
  • Patient who has performed the treatment to align the dental arches in the ambulatory of odontology at Hospital Municipal Infantil Menino Jesus;
  • Patient that have Goslow index 1, 2 or 3;
  • Patiente which have 2/3 of the root of the canine tooth (cleft region) formed.

Exclusion Criteria:

  • Prior alveolar surgery;
  • Canine teeth erupted before the bone graft;
  • Presence of co-morbidities;
  • Incomplete documentation;
  • Patients who have not done all the multidisciplinary treatment at Hospital Municipal Infantil Menino Jesus.

Sites / Locations

  • Hospital Sírio Libanês

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cleft lip and palate

Arm Description

5 Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment will be selected to be submited to alveolar bone tissue engineering surgery

Outcomes

Primary Outcome Measures

Amount of New Bone Mass Formed
The quantification of bone formation will be conducted by analysis of CT scans of alveolar cleft area that receive autogenous mesenchymal stem cells from dental pulp associated with the biomaterial 3 and 6 months after surgical procedure ( tissue engineering ) in comparison with CT Scan previously of tissue engineering surgery.Preoperative and follow-up examinations reveled progressive alveolar bone union in all patients. For these 5 patients final completion of the alveolar defect with an 89,5% mean bone height was detected 6 months postoperatively. We are still waiting the canine dental eruption at the new bone. For these group of patients the bone tissue engineering using autologous mesenchymal stem cells associated with biomaterial resulted in satisfactory bone healing.
Quality of Bone Regeneration
The quality of bone formation will be conducted by analysis of CT scans of alveolar cleft area through canine tooth eruption in these position of new bone formation by tissue engineering techniques. We are waiting the canine eruption at the mouth.

Secondary Outcome Measures

Full Information

First Posted
August 27, 2013
Last Updated
May 21, 2020
Sponsor
Hospital Sirio-Libanes
Collaborators
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT01932164
Brief Title
Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients
Official Title
Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
December 16, 2015 (Actual)
Study Completion Date
December 16, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Sirio-Libanes
Collaborators
Hospital Infantil Universitario Niño Jesús, Madrid, Spain

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to perform the bone tissue engineering to reconstruct the alveolar bone defect in cleft lip and palate patients using mesenchymal stem cells from deciduous dental pulp associated with a collagen and hydroxyapatite biomaterial (Geistlich Bio-Oss®) through prospective qualitative and quantitative analysis of bone neoformation.
Detailed Description
The reconstruction of the craniofacial skeleton in development between 2 and 10 years old, remains a major challenge for reconstructive plastic surgery. Local autogenous bone is practically unavailable, the distant bone graft has significant morbidity and use of alloplastic materials is incompatible with the growing facial skeleton. With the advent of bioengineered tissue, however, osteogenesis induced by the use of mesenchymal stem cells associated with biomaterials has become a potential solution to the shortage bone-related morbidity and donor bone in the region in pediatric patients. The association of mesenchymal stem cells to biomaterials has provided new bone formation and a significant reduction of morbidity, for rehabilitation of the alveolar bone in patients with cleft lip palate. To perform the rehabilitation of alveolar bone cleft, other donor regions of bone (iliac crest, ribs, skull) suffer morbidity for obtaining bone to be used in alveolar bone grafting. In order to eliminate the morbidity at the bone donor region for these patients and reduce costs of patient permanence in the operating room the aim of this study is to perform the bone tissue engineering to reconstruct the alveolar bone defect in cleft lip and palate patients using mesenchymal stem cells from deciduous dental pulp associated with a collagen and hydroxyapatite biomaterial (Geistlich Bio-Oss®) through prospective qualitative and quantitative analysis of bone neoformation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip and Palate
Keywords
Cleft lip and palate, Deciduous dental pulp stem cells, mesenchymal stem cells, tissue engineering, bone tissue engineering, bioengineering

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cleft lip and palate
Arm Type
Experimental
Arm Description
5 Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment will be selected to be submited to alveolar bone tissue engineering surgery
Intervention Type
Procedure
Intervention Name(s)
maxillary alveolar graft by tissue engineering
Other Intervention Name(s)
alveolar bone graft, bone tissue engineering, bone tissue engineering using mesenchymal stem cells
Intervention Description
Extraction of deciduous teeth of cleft lip and palate patients to obtain mesenchymal stem cells;
Intervention Type
Procedure
Intervention Name(s)
Bone tissue engineering using mesenchymal stem cells
Intervention Description
Secondary alveolar graft in patients with cleft lip and palate using using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite.
Primary Outcome Measure Information:
Title
Amount of New Bone Mass Formed
Description
The quantification of bone formation will be conducted by analysis of CT scans of alveolar cleft area that receive autogenous mesenchymal stem cells from dental pulp associated with the biomaterial 3 and 6 months after surgical procedure ( tissue engineering ) in comparison with CT Scan previously of tissue engineering surgery.Preoperative and follow-up examinations reveled progressive alveolar bone union in all patients. For these 5 patients final completion of the alveolar defect with an 89,5% mean bone height was detected 6 months postoperatively. We are still waiting the canine dental eruption at the new bone. For these group of patients the bone tissue engineering using autologous mesenchymal stem cells associated with biomaterial resulted in satisfactory bone healing.
Time Frame
6 months from surgical procedure for alveolar grafting;
Title
Quality of Bone Regeneration
Description
The quality of bone formation will be conducted by analysis of CT scans of alveolar cleft area through canine tooth eruption in these position of new bone formation by tissue engineering techniques. We are waiting the canine eruption at the mouth.
Time Frame
Three months after the graft

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of unilateral cleft lip and palate ; Patient who has performed the treatment to align the dental arches in the ambulatory of odontology at Hospital Municipal Infantil Menino Jesus; Patient that have Goslow index 1, 2 or 3; Patiente which have 2/3 of the root of the canine tooth (cleft region) formed. Exclusion Criteria: Prior alveolar surgery; Canine teeth erupted before the bone graft; Presence of co-morbidities; Incomplete documentation; Patients who have not done all the multidisciplinary treatment at Hospital Municipal Infantil Menino Jesus.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela F Bueno, PhD
Organizational Affiliation
Hospital Sírio-Libanês
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Sírio Libanês
City
São Paulo
ZIP/Postal Code
01308-060
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
16584868
Citation
Hibi H, Yamada Y, Ueda M, Endo Y. Alveolar cleft osteoplasty using tissue-engineered osteogenic material. Int J Oral Maxillofac Surg. 2006 Jun;35(6):551-5. doi: 10.1016/j.ijom.2005.12.007. Epub 2006 Apr 11.
Results Reference
background
PubMed Identifier
17667684
Citation
Gimbel M, Ashley RK, Sisodia M, Gabbay JS, Wasson KL, Heller J, Wilson L, Kawamoto HK, Bradley JP. Repair of alveolar cleft defects: reduced morbidity with bone marrow stem cells in a resorbable matrix. J Craniofac Surg. 2007 Jul;18(4):895-901. doi: 10.1097/scs.0b013e3180a771af.
Results Reference
background
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
derived

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Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients

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