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

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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

Tracking Information
First Submitted Date  ICMJE August 27, 2013
First Posted Date  ICMJE August 30, 2013
Results First Submitted Date  ICMJE March 18, 2015
Results First Posted Date  ICMJE March 30, 2015
Last Update Posted Date September 15, 2017
Actual Study Start Date  ICMJE May 2013
Actual Primary Completion Date December 16, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2015)
  • Amount of New Bone Mass Formed [ Time Frame: 6 months from surgical procedure for alveolar grafting; ]
    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 [ Time Frame: Three months after the graft ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 27, 2013)
  • Amount of New Bone Mass Formed [ Time Frame: 3 months from surgical procedure for alveolar grafting; ]
    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 months from surgical procedure of tissue engineering.
  • Quality of Bone Regeneration [ Time Frame: Three months after the graft ]
    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.
Change History Complete list of historical versions of study NCT01932164 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients
Official Title  ICMJE Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cleft Lip and Palate
Intervention  ICMJE
  • Procedure: maxillary alveolar graft by tissue engineering
    Extraction of deciduous teeth of cleft lip and palate patients to obtain mesenchymal stem cells;
    Other Names:
    • alveolar bone graft
    • bone tissue engineering
    • bone tissue engineering using mesenchymal stem cells
  • Procedure: 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.
Study Arms  ICMJE Experimental: 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
Interventions:
  • Procedure: maxillary alveolar graft by tissue engineering
  • Procedure: Bone tissue engineering using mesenchymal stem cells
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2013)
5
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 16, 2015
Actual Primary Completion Date December 16, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01932164
Other Study ID Numbers  ICMJE HSL 2013-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniela Franco Bueno, Hospital Sirio-Libanes
Study Sponsor  ICMJE Hospital Sirio-Libanes
Collaborators  ICMJE Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Investigators  ICMJE
Principal Investigator: Daniela F Bueno, PhD Hospital Sírio Libanês
PRS Account Hospital Sirio-Libanes
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP