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

Cleft Lip and Palate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932164
• Other study ID #: HSL 2013-04
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: December 16, 2015

Study information

• Verified date: May 2020
• Source: Hospital Sirio-Libanes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 16, 2015
• Est. primary completion date: December 16, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Brazil	Hospital Sírio Libanês	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Sirio-Libanes	Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View 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. Epub 2006 Apr 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months from surgical procedure for alveolar grafting;
Primary	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.	Three months after the graft