Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01932164
Recruitment Status : Completed
First Posted : August 30, 2013
Results First Posted : March 30, 2015
Last Update Posted : September 15, 2017
Sponsor:
Collaborator:
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Information provided by (Responsible Party):
Daniela Franco Bueno, Hospital Sirio-Libanes

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cleft Lip and Palate
Interventions Procedure: maxillary alveolar graft by tissue engineering
Procedure: Bone tissue engineering using mesenchymal stem cells
Enrollment 5
Recruitment Details the recruitment of 5 patients was performed at dentistry department of Hospital Menino Jesus between june and august 2013.
Pre-assignment Details  
Arm/Group Title Cleft Lip and Palate
Hide Arm/Group Description

Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment

maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite.

Period Title: Overall Study
Started 5 [1]
Cleft Lip and Palate 5 [2]
Cleft Lip and Palate 5 [3]
Cleft Lip and Palate 5 [4]
Cleft Lip and Palate 5 [5]
Cleft Lip and Palate 5 [6]
Completed 5 [7]
Not Completed 0
[1]
It was performed the selection of 5 patients to participate of these study (08/2013)
[2]
It was performed de extraction of deciduous teeth of 5 cleft lip/palate patients (09/2013)
[3]
Dental pulp was obtained from teeth of 5 different patients (09/2013)
[4]
Mesenchymal stem cell obtained from dental pulp of 5patients was obtained, caractherized and frozen
[5]
Alveolar bone graft surgeries were did using their dental pulp stem cells with biomaterial
[6]
The surgeries were performed between december 2013 and june 2014.
[7]
In all 5 patients we observed bone formation closing the alveolar cleft after 6 months
Arm/Group Title Cleft Lip and Palate
Hide Arm/Group 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

maxillary alveolar graft by tissue engineering: Extraction of deciduous teeth of cleft lip and palate patients to obtain mesenchymal stem cells;

Bone tissue engineering using mesenchymal stem cells: 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.

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
5
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
3
  60.0%
Male
2
  40.0%
[1]
Measure Description: 3 female and 2 male children with cleft lip and palate were submited to bone tissue engineering alveolar bone graft.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 5 participants
5
1.Primary Outcome
Title Amount of New Bone Mass Formed
Hide 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;
Hide Outcome Measure Data
Hide Analysis Population Description
3 females and 2 males with cleft lip and palate
Arm/Group Title Cleft Lip and Palate
Hide Arm/Group Description:

Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment

maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite.

Overall Number of Participants Analyzed 5
Mean (95% Confidence Interval)
Unit of Measure: percentage of bone formation
89
(89 to 100)
2.Primary Outcome
Title Quality of Bone Regeneration
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cleft Lip and Palate
Hide Arm/Group Description:

Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment

maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite.

Overall Number of Participants Analyzed 5
Mean (80% Confidence Interval)
Unit of Measure: percentage of bone filling
90
(80 to 100)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cleft Lip and Palate
Hide Arm/Group Description

Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment

maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite.

All-Cause Mortality
Cleft Lip and Palate
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cleft Lip and Palate
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cleft Lip and Palate
Affected / at Risk (%)
Total   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dra Daniela Franco Bueno
Organization: Hospital Sirio Libanes
Phone: +5511997900159
EMail: dbuenousp@gmail.com
Layout table for additonal information
Responsible Party: Daniela Franco Bueno, Hospital Sirio-Libanes
ClinicalTrials.gov Identifier: NCT01932164     History of Changes
Other Study ID Numbers: HSL 2013-04
First Submitted: August 27, 2013
First Posted: August 30, 2013
Results First Submitted: March 18, 2015
Results First Posted: March 30, 2015
Last Update Posted: September 15, 2017