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
About this trial
This is an interventional treatment trial for Periodontitis, Chronic focused on measuring Periodontitis, Mesenchymal stem cells
Eligibility Criteria
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
NCT ID
NCT04446897
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
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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