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

• ClinicalTrials.gov Identifier: NCT01932164
• Recruitment Status: Completed
• First Posted: August 30, 2013
• Results First Posted: March 30, 2015
• Last Update Posted: May 28, 2020
• Sponsor: Hospital Sirio-Libanes
• Collaborator: Hospital Infantil Universitario Niño Jesús, Madrid, Spain
• Information provided by (Responsible Party): Daniela Franco Bueno, Hospital Sirio-Libanes

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cleft Lip and Palate	Procedure: maxillary alveolar graft by tissue engineering; Procedure: Bone tissue engineering using mesenchymal stem cells	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients
• Actual Study Start Date: May 2013
• Actual Primary Completion Date: December 16, 2015
• Actual Study Completion Date: December 16, 2015

Arms and Interventions

Arm

Intervention/treatment

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

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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 7 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Brazil

Hospital Sírio Libanês

São Paulo, Brazil, 01308-060

Sponsors and Collaborators

Hospital Sirio-Libanes

Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Investigators

• Principal Investigator: Daniela F Bueno, PhD; Hospital Sírio-Libanês

More Information

Publications:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Daniela Franco Bueno, DDS; PhD, Hospital Sirio-Libanes
• ClinicalTrials.gov Identifier: NCT01932164
• Other Study ID Numbers: HSL 2013-04
• First Posted: August 30, 2013
• Results First Posted: March 30, 2015
• Last Update Posted: May 28, 2020
• Last Verified: May 2020

Keywords provided by Daniela Franco Bueno, Hospital Sirio-Libanes:

Cleft lip and palate; Deciduous dental pulp stem cells; mesenchymal stem cells; tissue engineering; bone tissue engineering; bioengineering

Additional relevant MeSH terms:

Cleft Lip; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities