We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01932164
First Posted: August 30, 2013
Last Update Posted: September 15, 2017
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.
Collaborator:
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Information provided by (Responsible Party):
Daniela Franco Bueno, Hospital Sirio-Libanes
Results First Submitted: March 18, 2015  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
the recruitment of 5 patients was performed at dentistry department of Hospital Menino Jesus between june and august 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cleft Lip and Palate

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.


Participant Flow:   Overall Study
    Cleft Lip and Palate
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



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cleft Lip and Palate

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.


Baseline Measures
   Cleft Lip and Palate 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      5 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
 
Female      3  60.0% 
Male      2  40.0% 
[1] 3 female and 2 male children with cleft lip and palate were submited to bone tissue engineering alveolar bone graft.
Region of Enrollment 
[Units: Participants]
 
Brazil   5 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Amount of New Bone Mass Formed   [ Time Frame: 6 months from surgical procedure for alveolar grafting; ]

2.  Primary:   Quality of Bone Regeneration   [ Time Frame: Three months after the graft ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dra Daniela Franco Bueno
Organization: Hospital Sirio Libanes
phone: +5511997900159
e-mail: dbuenousp@gmail.com


Publications:

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



To Top