Clinical trial NCT02209311: Effectiveness and Safety of Method of Maxilla Alveolar Process Reconstruction Using Synthetic Tricalcium Phosphate and Autologous MMSCs
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Partially Edentulous Maxilla
Alveolar Bone Atrophy
Alveolar Bone Loss
Keywords: Alveolar Bone Loss
Alveolar Bone Atrophy
Dental Implantation
Bone Tissue Reconstruction
Sinus Lift
Autologous Multipotent Mesenchymal Stem Cell
Autologous MMSCs
Synthetic Tricalcium Phosphate
Tissue Engineered Construction
Oral Mucosa
Lead sponsor: Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
Sponsor class: OTHER_GOV
First posted: 2014-08-05
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
timeFrame: 1 week after treatment
Secondary outcomes:
measure: Quality of life monitoring
timeFrame: up to 24 weeks after treatment
measure: Changes in bone tissue volume
timeFrame: up to 24 weeks after treatment
measure: Correlation of morphometrical analysis using cone beam CT scan with absolute value of the newly formed bone
timeFrame: 24 weeks after treatment
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: 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
city: Moscow
country: Russian Federation
facility: A.I. Evdokimov Moscow State Medical Stomatological University
Study officials:
affiliation: A.I. Evdokimov Moscow State Medical Stomatological University
name: Grigory Volozhin A Volozhin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: 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
name: Ilya I Eremin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: