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

Alveolar Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02209311
• Other study ID #: RU-CCH-06-01-14
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• First received: August 4, 2014
• Last updated: November 29, 2016
• Start date: September 2014
• Est. completion date: March 2018

Study information

• Verified date: November 2016
• Source: Central Clinical Hospital with Outpatient Health Center of Business Administration for the President of Russian Federati
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: March 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Partially edentulous maxilla

• Height of the bone tissue in the area of reconstruction 1 - 5 mm according to results of cone-beam computed tomography

• Minimal height of the augmentation - 8 mm

• Volume of bone tissue deficiency of the alveolar process of the maxilla 3 - 5 cm3

• Implant installation scheduled to be at least 6 months after sinus-lift operation

• Patient is familiar with Participant information sheet

• Patient signed informed consent form

Non-inclusion Criteria:

• Chronic and acute ear, nose and throat diseases, including maxillary sinusitis, foreign bodies in the maxillary sinus, odontogenic and not odontogenic maxillary sinus cyst

• Medical history of surgery on maxillary sinuses during preceding 6 months prior to implantation of tissue engineered construction

• Progressive somatic disease (clinically significant diseases of the cardiovascular, hematopoietic or endocrine system, systemic diseases, immunopathological states)

• Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy

• Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and alcohol abuse etc.)

• Significant weight loss (> 10% of body weight in the previous year) of unknown etiology

• Patient prescribed for any medications with proven effect on bone metabolism

• Diabetes mellitus, disorders of thyroid and parathyroid glands

• Clinically significant abnormalities in results of laboratory tests

• Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion

Exclusion Criteria:

• Patient's refusal from the further participation in trial

• Patient's refusal from compliance with the requirements of contraception during the participation in research

• Plaque index (PI)> 15%

• Sulcus bleeding index (SBI) > 10%

• Chronic kidney disease IV - V stages (creatinine clearance < 30 mL/min estimated by Cockroft-Gault formula)

• Confirmed syphilis, HIV, hepatitis B or C infections

Dropout Criteria:

• Perforation of the Schneider's membrane more than 5 mm on the stage of the sinus-lift operation

• Pregnancy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Oral mucosa biopsy

• Sinus lift with implantation of tissue engineered construction

Device:
• Dental implant

Locations

Country	Name	City	State
Russian Federation	A.I. Evdokimov Moscow State Medical Stomatological University	Moscow
Russian Federation	Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation; Center for Biomedical Technologies	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Central Clinical Hospital with Outpatient Health Center of Business Administration for the President of Russian Federati

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of serious adverse events (SAEs) and serious adverse reactions (SARs)		1 week after treatment	Yes
Secondary	Quality of life monitoring	Quality of life estimated by validated questionnaire: the Short Form (36) Health Survey (SF-36).	up to 24 weeks after treatment	No
Secondary	Changes in bone tissue volume	Changes in volume and density of bone tissue at the site of manipulation and newly formed bone micro-architecture assessed by cone beam CT (morphometrical analysis using Hounsfield unit measurements)	up to 24 weeks after treatment	No
Secondary	Correlation of morphometrical analysis using cone beam CT scan with absolute value of the newly formed bone	Biopsy of bone tissue at the site of sinus lift will be performed as a part of dental implant installation. Bone sample will be evaluated histologically: absolute value of the newly formed bone will be calculated using histomorphometrical analysis.	24 weeks after treatment	No