Treatment of Gingival Recession Using Mesenchymal Stem Cells

June 13, 2020 updated by: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Treatment of Gingival Recession Using Autologous Adipose-derived Mesenchymal Stem Cells

Treatment of patients with gingival recession by injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus, 220072
        • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-gingival recession

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: mesenchymal stem cells
standard treatment according to clinical protocols plus mesenchymal stem cells
Biological: mesenchymal stem cells
autologous mesenchymal stem cells
Other: standard treatment
standard treatment according to clinical protocols
ACTIVE_COMPARATOR: control
standard treatment according to clinical protocols
Other: standard treatment
standard treatment according to clinical protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients cured
Time Frame: 1 month
number of patients cured
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Belarusian Medical Academy of Post-Graduate Education

Investigators

  • Study Director: Sergey Rubnikovich, Prof, Head of the Department of Prosthodontics of BMAPE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

June 13, 2020

First Submitted That Met QC Criteria

June 13, 2020

First Posted (ACTUAL)

June 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 17, 2020

Last Update Submitted That Met QC Criteria

June 13, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBCE_MSC(GR2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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