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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Information provided by (Responsible Party):
Daniela Franco Bueno, Hospital Sirio-Libanes
ClinicalTrials.gov Identifier:
NCT01932164
First received: August 27, 2013
Last updated: March 18, 2015
Last verified: August 2013
Results First Received: March 18, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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
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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
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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  
Number of Participants  
[units: participants]
  5  
Age  
[units: participants]
 
<=18 years     5  
Between 18 and 65 years     0  
>=65 years     0  
Gender [1]
[units: participants]
 
Female     3  
Male     2  
Region of Enrollment  
[units: participants]
 
Brazil     5  
[1] 3 female and 2 male children with cleft lip and palate were submited to bone tissue engineering alveolar bone graft.



  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 ]
Results not yet reported.   Anticipated Reporting Date:   03/2015   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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
Study First Received: August 27, 2013
Results First Received: March 18, 2015
Last Updated: March 18, 2015
Health Authority: Brazil: National Committee of Ethics in Research