Gingival RecessionPhase 1/2NCT04434794
Treatment of Gingival Recession Using Mesenchymal Stem Cells
A Phase 1/2 study testing mesenchymal stem cells and standard treatment in people with Gingival Recession, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
Trial summary
Treatment of patients with gingival recession by injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- mesenchymal stem cells and standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Jan 2018to 31 Dec 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -gingival recession
Who cannot join
- pregnancy
- breast-feeding
- acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
- mental disorders
Trial locations and contacts
1 site in 1 country.
Belarus1 site
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Minsk, 220072
About this study
Official title: 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
Read the 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).
- Conditions
- Gingival Recession
- Being tested
- mesenchymal stem cells, standard treatment
- Keywords
- Gingival Recession
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal stem cellsBiological
autologous mesenchymal stem cells
standard treatmentOther
standard treatment according to clinical protocols
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stem cells | Experimental | standard treatment according to clinical protocols plus mesenchymal stem cells Receives: Biological: mesenchymal stem cells; Other: standard treatment |
| control | Active comparator | standard treatment according to clinical protocols Receives: Other: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients cured
number of patients cured
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
- Sponsor type
- Other government
- Collaborators
- Belarusian Medical Academy of Post-Graduate Education
- Responsible party
- Sponsor
- Investigators
- Igor D Volotovski, Prof, Study director, Head of the Lab of Institute of Biophysics and Cell EngineeringSergey Rubnikovich, Prof, Study director, Head of the Department of Prosthodontics of BMAPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434794
- Sponsor's protocol ID
- IBCE_MSC(GR2)
- Status last verified
- Jun 2020
- First submitted
- 13 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Gingival Recession Using Autologous Adipose-derived Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT04434794
- Acronym / sponsor ID
- IBCE_MSC(GR2)
- Conditions
- Gingival Recession
- Keywords
- Gingival Recession
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusOther government
- Collaborators
- Belarusian Medical Academy of Post-Graduate Education
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mesenchymal stem cells | Experimental | Biological: mesenchymal stem cells, Other: standard treatmentstandard treatment according to clinical protocols plus mesenchymal stem cells |
| control | Active comparator | Other: standard treatmentstandard treatment according to clinical protocols |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -gingival recession
Key exclusion criteria (4 listed)
- pregnancy
- breast-feeding
- acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
- mental disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mesenchymal stem cellsautologous mesenchymal stem cells | Biological | mesenchymal stem cells |
| standard treatmentstandard treatment according to clinical protocols | Other | control, mesenchymal stem cells |
Primary outcome
number of patients cured
Time frame: 1 month
number of patients cured
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor D Volotovski, Prof study director
Head of the Lab of Institute of Biophysics and Cell Engineering
Sergey Rubnikovich, Prof study director
Head of the Department of Prosthodontics of BMAPE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing mesenchymal stem cells and standard treatment in people with Gingival Recession, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients cured (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.