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Treatment of Gingival Recession Using Mesenchymal Stem Cells

Primary Purpose

Gingival Recession

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 Gingival Recession focused on measuring Gingival Recession

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-gingival recession

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

control

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 13, 2020
Last Updated
June 13, 2020
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
NCT04434794
Brief Title
Treatment of Gingival Recession Using Mesenchymal Stem Cells
Official Title
Treatment of Gingival Recession Using Autologous Adipose-derived Mesenchymal Stem Cells
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (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 patients with gingival recession by injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel
Detailed Description
Treatment of patients with gingival recession by injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel (1×106cells/0.2 ml). The volume of the mixture is divided into 4 equal injections in the gingival region of one tooth (one place injection volume is 0.05 ml of mixture).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
Gingival Recession

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
27 (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
control
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
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -gingival recession 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 D 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

Plan to Share IPD
No

Learn more about this trial

Treatment of Gingival Recession Using Mesenchymal Stem Cells

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