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

NCT02209311 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-11-30

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

Oral mucosa biopsy

PROCEDURE

Sinus lift with implantation of tissue engineered construction

DEVICE

Dental implant

Sponsors & Collaborators

  • Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation

    lead OTHER_GOV

Principal Investigators

  • Grigory Volozhin A Volozhin, MD, PhD · A.I. Evdokimov Moscow State Medical Stomatological University

  • Ilya I Eremin, MD, PhD · 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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-10-31
Completion
2018-03-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02209311 on ClinicalTrials.gov