NCT02209311

Effectiveness and Safety of Method of Maxilla Alveolar Process Reconstruction Using Synthetic Tricalcium Phosphate and Autologous MMSCs

Effectiveness and Safety of Method of Maxilla Alveolar Process Reconstruction Using Tissue Engineered Construction Based on a Synthetic Tricalcium Phosphate and Autologous Multipotent Mesenchymal Stromal Cells Obtained From Oral Mucosa

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation · Other Government
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Autologous MMSCs will be isolated from oral mucosa biopsy sample and expanded in vitro.Tissue engineered construction will be created using synthetic tricalcium phosphate and autologous MMSCs. Patients will undergo sinus lift procedure with implantation of created tissue-engineered construction. This is a single arm study with no control. All patients receive cell therapy.

Detailed description

Patients with verified diagnosis partially edentulous maxilla and alveolar bone atrophy will undergo oral mucosa biopsy and autologous MMSCs will be derived and expanded in vitro during 3-4 weeks. After that tissue engineered construction will be created using synthetic tricalcium phosphate and autologous MMSCs. Patients will undergo sinus lift procedure with implantation of created tissue-engineered construction. Six months later patients will undergo dental implant installation. Biopsy of bone tissue at the site of sinus lift will be performed as a part of dental implant installation with subsequent histological analysis of bone specimen.

Conditions

• Partially Edentulous Maxilla
• Alveolar Bone Atrophy
• Alveolar Bone Loss

Interventions

Type	Name	Description
PROCEDURE	Oral mucosa biopsy
PROCEDURE	Sinus lift with implantation of tissue engineered construction
DEVICE	Dental implant

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-10-01
• Completion: 2018-03-01
• First posted: 2014-08-05
• Last updated: 2016-11-30

Locations

2 sites across 1 country: Russia