NCT04434794

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2018

Typical duration 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

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

2 years

First QC Date

June 13, 2020

Last Update Submit

June 13, 2020

Conditions

Gingival Recession

Keywords

Gingival Recession

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

control

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

controlmesenchymal stem cells

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • gingival recession

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

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Igor D 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 13, 2020

First Posted

June 17, 2020

Study Start

January 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

June 17, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)