NCT04446897

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

August 3, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

June 22, 2020

Last Update Submit

February 8, 2021

Conditions

Periodontitis, Chronic

Keywords

PeriodontitisMesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

  • number of patients cured

    number of patients cured

    1 month

Study Arms (2)

mesenchymal stem cells

EXPERIMENTAL

standard treatment according to clinical protocols plus mesenchymal stem cells

Biological: mesenchymal stem cellsOther: standard treatment

standard treatment

ACTIVE COMPARATOR

standard treatment according to clinical protocols

Other: standard treatment

Interventions

mesenchymal stem cellsBIOLOGICAL

autologous mesenchymal stem cells

mesenchymal stem cells
standard treatmentOTHER

standard treatment according to clinical protocols

mesenchymal stem cellsstandard treatment

Eligibility Criteria

Age70 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • \- chronic medium-severe periodontitis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Minsk, 220072, Belarus

Location

MeSH Terms

Conditions

Chronic PeriodontitisPeriodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Igor Volotovski, Prof

    Head of the Lab of Institute of Biophysics and Cell Engineering

    STUDY DIRECTOR

  • Sergey Rubnikovich, Prof

    Head of the Department of Prosthodontics of BMAPE

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2020

First Posted

June 25, 2020

Study Start

August 3, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations

BE(1)