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

NCT ID: NCT01932164

Last Updated: 2020-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-12-16

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.

Conditions

Cleft Lip and Palate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

maxillary alveolar graft by tissue engineering

Intervention Type: PROCEDURE

Extraction of deciduous teeth of cleft lip and palate patients to obtain mesenchymal stem cells;

Bone tissue engineering using mesenchymal stem cells

Intervention Type: PROCEDURE

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.

Interventions

maxillary alveolar graft by tissue engineering

Extraction of deciduous teeth of cleft lip and palate patients to obtain mesenchymal stem cells;

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

alveolar bone graft; bone tissue engineering; bone tissue engineering using mesenchymal stem cells

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Infantil Universitario Niño Jesús, Madrid, Spain

OTHER

Sponsor Role: collaborator

Hospital Sirio-Libanes

OTHER

Sponsor Role: lead

Responsible Party

Daniela Franco Bueno

DDS; PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniela F Bueno, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Sírio-Libanês

Locations

Hospital Sírio Libanês

São Paulo, , Brazil

Countries

Brazil

References

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. doi: 10.1016/j.ijom.2005.12.007. Epub 2006 Apr 11.

Reference Type: BACKGROUND

PMID: 16584868 (View on PubMed)

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. doi: 10.1097/scs.0b013e3180a771af.

Reference Type: BACKGROUND

PMID: 17667684 (View on PubMed)

Tanikawa DYS, Pinheiro CCG, Almeida MCA, Oliveira CRGCM, Coudry RA, Rocha DL, Bueno DF. Deciduous Dental Pulp Stem Cells for Maxillary Alveolar Reconstruction in Cleft Lip and Palate Patients. Stem Cells Int. 2020 Mar 12;2020:6234167. doi: 10.1155/2020/6234167. eCollection 2020.

Reference Type: DERIVED

PMID: 32256610 (View on PubMed)

Other Identifiers

HSL 2013-04

Identifier Type: -

Identifier Source: org_study_id