Treatment of Chronic Medium-severe Periodontitis With Mesenchymal Stem Cells Predifferentiated in Osteogenic Direction

NCT ID: NCT04446897

Last Updated: 2021-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-03

Study Completion Date

2020-12-31

Brief Summary

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Treatment of chronic medium-severe periodontitis with mesenchymal stem cells and mesenchymal stem cells predifferentiated in osteogenic direction

Detailed Description

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The bone defect will be filled with a porous membrane based on bone collagen measuring 5x5 mm or more with mesenchymal stem cells and mesenchymal stem cells predifferentiated in osteogenic direction

Conditions

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Periodontitis, Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mesenchymal stem cells

standard treatment according to clinical protocols plus mesenchymal stem cells

Group Type EXPERIMENTAL

mesenchymal stem cells

Intervention Type BIOLOGICAL

autologous mesenchymal stem cells

standard treatment

Intervention Type OTHER

standard treatment according to clinical protocols

standard treatment

standard treatment according to clinical protocols

Group Type ACTIVE_COMPARATOR

standard treatment

Intervention Type OTHER

standard treatment according to clinical protocols

Interventions

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mesenchymal stem cells

autologous mesenchymal stem cells

Intervention Type BIOLOGICAL

standard treatment

standard treatment according to clinical protocols

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- chronic medium-severe periodontitis

Exclusion Criteria

* pregnancy
* breast-feeding
* acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
* mental disorders
Minimum Eligible Age

70 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belarusian Medical Academy of Post-Graduate Education

OTHER

Sponsor Role collaborator

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Igor Volotovski, Prof

Role: STUDY_DIRECTOR

Head of the Lab of Institute of Biophysics and Cell Engineering

Sergey Rubnikovich, Prof

Role: STUDY_DIRECTOR

Head of the Department of Prosthodontics of BMAPE

Locations

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Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Minsk, , Belarus

Site Status

Countries

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Belarus

Other Identifiers

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IBCE_MSC(periodontitis)

Identifier Type: -

Identifier Source: org_study_id

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