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

Primary Purpose

Periodontitis, Chronic

Status
Completed
Phase
Phase 1
Locations
Belarus
Study Type
Interventional
Intervention
mesenchymal stem cells
standard treatment
Sponsored by
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis, Chronic focused on measuring Periodontitis, Mesenchymal stem cells

Eligibility Criteria

70 Years - 70 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- chronic medium-severe periodontitis

Exclusion Criteria:

  • pregnancy
  • breast-feeding
  • acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
  • mental disorders

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mesenchymal stem cells

standard treatment

Arm Description

standard treatment according to clinical protocols plus mesenchymal stem cells

standard treatment according to clinical protocols

Outcomes

Primary Outcome Measures

number of patients cured
number of patients cured

Secondary Outcome Measures

Full Information

First Posted
June 22, 2020
Last Updated
February 8, 2021
Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Belarusian Medical Academy of Post-Graduate Education
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1. Study Identification

Unique Protocol Identification Number
NCT04446897
Brief Title
Treatment of Chronic Medium-severe Periodontitis With Mesenchymal Stem Cells Predifferentiated in Osteogenic Direction
Official Title
Treatment of Chronic Medium-severe Periodontitis With Mesenchymal Stem Cells Predifferentiated in Osteogenic Direction Immobilised on a Biodegradable Carrier
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Belarusian Medical Academy of Post-Graduate Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Chronic
Keywords
Periodontitis, Mesenchymal stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mesenchymal stem cells
Arm Type
Experimental
Arm Description
standard treatment according to clinical protocols plus mesenchymal stem cells
Arm Title
standard treatment
Arm Type
Active Comparator
Arm Description
standard treatment according to clinical protocols
Intervention Type
Biological
Intervention Name(s)
mesenchymal stem cells
Intervention Description
autologous mesenchymal stem cells
Intervention Type
Other
Intervention Name(s)
standard treatment
Intervention Description
standard treatment according to clinical protocols
Primary Outcome Measure Information:
Title
number of patients cured
Description
number of patients cured
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - chronic medium-severe periodontitis Exclusion Criteria: pregnancy breast-feeding acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis mental disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Igor Volotovski, Prof
Organizational Affiliation
Head of the Lab of Institute of Biophysics and Cell Engineering
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sergey Rubnikovich, Prof
Organizational Affiliation
Head of the Department of Prosthodontics of BMAPE
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
City
Minsk
ZIP/Postal Code
220072
Country
Belarus

12. IPD Sharing Statement

Learn more about this trial

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

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