Chronic EndometritisPhase 1/2NCT04432467
Fertility Restoration Using Autologous Mesenchymal Stem Cells
A Phase 1/2 study testing Autologous mesenchymal stem cells and standard treatment in people with Chronic Endometritis and Uterus; Scar, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
Trial summary
Treatment of the patients with scarring and adhesions in the uterus resulting from caesarean section or chronic inflammation in the mucosa of the uterus and fallopian tubes and preventing the occurrence of these effects in the future Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Chronic Endometritis, Uterus; Scar, Uterine Synechiae
- What is being tested?
- Autologous mesenchymal stem cells and standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Oct 2020to 30 Sep 2021
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- chronic endometritis
- postoperative uterus scars
- uterine synechia
- fallopian tube obstruction
- absence of acute inflammation in the uterus
Who cannot join
- Patients with genetic diseases of muscle and connective tissue;
- Patients with malformations of the uterus;
- Acute and chronic infectious diseases: HIV, mycoplasma infection, hepatitis B and C, syphilis; autoimmune diseases; oncological diseases; continuous hormonal therapy with cytostatics corticosteroids; acute noncommunicable diseases;
- mental disorders;
- Drug or alcohol addiction;
- Benign tumors of uterus and appendages;
- Hypersensitivity to any component of the studied biomedical cell product.
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: Fertility Restoration Using Autologous Adipose Tissue Derived Mesenchymal Stem Cells
Treatment of the patients with scarring and adhesions in the uterus resulting from caesarean section or chronic inflammation in the mucosa of the uterus and fallopian tubes and preventing the occurrence of these effects in the future
Read the detailed description
The aim of the project is to develop a biomedical cell product based on autologous adipose tissue derived mesenchymal stem cells and a biodegradable carrier for highly effective treatment and prevention of scarring and adhesions in the uterus acquired as a result of cesarean section or chronic inflammatory processes in the uterine mucosa and fallopian tubes; to conduct the clinical trials of the biomedical cell product in the treatment of uterus scarring and infertility in women.
- Being tested
- Autologous mesenchymal stem cells, standard treatment
- Keywords
- Fertility restoration, Mesenchymal stem cells
- Medical subject headings
- Cicatrix, Gynatresia, Fallopian Tube Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous mesenchymal stem cellsBiological
Autologous adipose tissue-derived mesenchymal stem cells
standard treatmentOther
standard treatment according to clinical protocols
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stem cells | Experimental | Patients with impending caesarean section or with chronic inflammation in the mucosa of the uterus and fallopian tubes receiving standard treatment and mesenchymal stem cells Receives: Biological: Autologous mesenchymal stem cells; Other: standard treatment |
| control | Active comparator | Patients with impending caesarean section or with chronic inflammation in the mucosa of the uterus and fallopian tubes receiving standard treatment Receives: Other: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cured patients
Number of patients cured
Measured: 6 months
Number of patients with treatment-related adverse events
MSC application related adverse events assessed by blood count, liver and function tests
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Oct 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic EndometritisStudies 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
- 10 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, Dr, Study director, Head of the Lab of Institute of Biophysics and Cell Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432467
- Sponsor's protocol ID
- IBCE_MSC(Fertility)
- Status last verified
- Dec 2021
- First submitted
- 11 Jun 2020
- Last updated
- 10 Dec 2021
- 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 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Restoration Using Autologous Adipose Tissue Derived Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT04432467
- Acronym / sponsor ID
- IBCE_MSC(Fertility)
- Keywords
- Fertility restoration, Mesenchymal stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 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 Oct 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 16 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 the patients with scarring and adhesions in the uterus resulting from caesarean section or chronic inflammation in the mucosa of the uterus and fallopian tubes and preventing the occurrence of these effects in the future
Detailed description
The aim of the project is to develop a biomedical cell product based on autologous adipose tissue derived mesenchymal stem cells and a biodegradable carrier for highly effective treatment and prevention of scarring and adhesions in the uterus acquired as a result of cesarean section or chronic inflammatory processes in the uterine mucosa and fallopian tubes; to conduct the clinical trials of the biomedical cell product in the treatment of uterus scarring and infertility in women.
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: Autologous mesenchymal stem cells, Other: standard treatmentPatients with impending caesarean section or with chronic inflammation in the mucosa of the uterus and fallopian tubes receiving standard treatment and mesenchymal stem cells |
| control | Active comparator | Other: standard treatmentPatients with impending caesarean section or with chronic inflammation in the mucosa of the uterus and fallopian tubes receiving standard treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- chronic endometritis
- postoperative uterus scars
- uterine synechia
- fallopian tube obstruction
- absence of acute inflammation in the uterus
Key exclusion criteria (7 listed)
- Patients with genetic diseases of muscle and connective tissue;
- Patients with malformations of the uterus;
- Acute and chronic infectious diseases: HIV, mycoplasma infection, hepatitis B and C, syphilis; autoimmune diseases; oncological diseases; continuous hormonal therapy with cytostatics corticosteroids; acute noncommunicable diseases;
- mental disorders;
- Drug or alcohol addiction;
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 |
|---|---|---|
| Autologous mesenchymal stem cellsAutologous adipose tissue-derived mesenchymal stem cells | Biological | mesenchymal stem cells |
| standard treatmentstandard treatment according to clinical protocols | Other | control, mesenchymal stem cells |
Primary outcome
Number of cured patients
Time frame: 6 months
Number of patients cured
Number of patients with treatment-related adverse events
Time frame: 4 weeks
MSC application related adverse events assessed by blood count, liver and function tests
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 10 Dec 2021.
- 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, Dr study director
Head of the Lab of Institute of Biophysics and Cell Engineering
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 Autologous mesenchymal stem cells and standard treatment in people with Chronic Endometritis and Uterus; Scar, 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 5 inclusion and 7 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 10 Dec 2021. 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 cured patients (time frame: 6 months). The study lists 2 primary outcomes in all. 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 10 Dec 2021; AzTrials last refreshed its copy on 1 Nov 2026.