Recurrent Pregnancy LossPhase 1/2NCT05520112
Treatment of Recurrent Pregnancy Loss Using Mesenchymal Stem Cells
A Phase 1/2 study testing Mesenchymal stem cells capable of differentiation in the endometrial-decidual direction and Standard treatment according to the clinical protocols in people with Recurrent Pregnancy Loss, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
Trial summary
Treatment of Recurrent pregnancy loss using mesenchymal stem cells capable of differentiation in the endometrial-decidual direction. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Recurrent Pregnancy Loss
- What is being tested?
- Mesenchymal stem cells capable of differentiation in the endometrial-decidual direction and Standard treatment according to the clinical protocols
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Nov 2022to 31 Dec 2023
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female patients of reproductive age 18-49 years;
- recurrent pregnancy loss without current pregnancy with thin endometrium;
- unsuccessful IVF cycles due to thin endometrium;
- endometrial thickness is ≤6 mm in the first and second phases of the menstrual cycle;
- uterine infertility associated with endometrial hypoplasia;
- the absence of genetic diseases that prevent pregnancy;
- absence of taking hormonal drugs for 3 months prior to enrollment in the study.
Who cannot join
- patients with congenital malformations of the genital organs: agenesis and aplasia of the uterus, bicornuate uterus, unicornuate uterus, congenital fistula between the uterus and the digestive and urinary tracts, other congenital anomalies of the body and cervix. congenital anomaly of the body and cervix, unspecified, other specified developmental anomalies;
- acute inflammatory processes in the uterus;
- acute or chronic infectious and non-infectious diseases in the acute stage, including HIV, hepatitis B and C, syphilis, tuberculosis, chlamydia, myco-, ureaplasmosis, herpes, toxoplasmosis, rubella, cytomegalovirus, gonorrhea, trichomoniasis, etc.;
- autoimmune diseases;
- patients with malignant tumor including a history;
- patients with benign tumors of the uterus and appendages;
Show all 11Show fewer
- miscarriage not associated with a thin endometrium, including immunological origin;
- hyper- or hypogonadotropic insufficiency of ovarian function, hyperandrogenemia of any origin;
- allergic reactions in the acute stage, established hypersensitivity to any component of the biomedical cell product;
- permanent therapy with cytostatics, hormones;
- mental and behavioral disorders that make it impossible for patients to participate in the study, drug and/or alcohol addiction.
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 Recurrent Pregnancy Loss Using Mesenchymal Stem Cells Capable of Differentiation in the Endometrial-decidual Direction
Treatment of Recurrent pregnancy loss using mesenchymal stem cells capable of differentiation in the endometrial-decidual direction.
Read the detailed description
Treatment of Recurrent pregnancy (characterized by the presense of thin endometrium) loss using mesenchymal stem cells capable of differentiation in the endometrial-decidual direction.
- Conditions
- Recurrent Pregnancy Loss
- Being tested
- Mesenchymal stem cells capable of differentiation in the endometrial-decidual direction, Standard treatment according to the clinical protocols
- Keywords
- Recurrent Pregnancy Loss, Mesenchymal stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cells capable of differentiation in the endometrial-decidual directionBiological
Mesenchymal stem cells capable of differentiation in the endometrial-decidual direction
Standard treatment according to the clinical protocolsOther
Standard treatment of Recurrent Pregnancy Loss according to the clinical protocols
| Study group | Role | What they receive |
|---|---|---|
| Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC | Experimental | Experimental: Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC Receives: Biological: Mesenchymal stem cells capable of differentiation in the endometrial-decidual direction; Other: Standard treatment according to the clinical protocols |
| Standard treatment according to the clinical protocols | Active comparator | Standard treatment of Recurrent Pregnancy Loss according to the clinical protocols Receives: Other: Standard treatment according to the clinical protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Measured: 1 year
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Measured: 1 month
Percent of patients with successful pregnancy
Percent of patients with successful pregnancy within 1 year after treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Nov 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pregnancy LossStudies 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
- 20 participants (estimated)
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
- Andrei Hancharou, Dr, Study chair, Institute for biophysics and cellular engineering NAS of Belarus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520112
- Sponsor's protocol ID
- IBCE_MSC(Endometrial)
- Status last verified
- Aug 2022
- First submitted
- 26 Aug 2022
- Last updated
- 29 Aug 2022
- 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 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Recurrent Pregnancy Loss Using Mesenchymal Stem Cells Capable of Differentiation in the Endometrial-decidual Direction
- ClinicalTrials.gov ID
- NCT05520112
- Acronym / sponsor ID
- IBCE_MSC(Endometrial)
- Conditions
- Recurrent Pregnancy Loss
- Keywords
- Recurrent Pregnancy Loss, Mesenchymal stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- 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 Nov 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 29 Aug 2022 (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 Recurrent pregnancy loss using mesenchymal stem cells capable of differentiation in the endometrial-decidual direction.
Detailed description
Treatment of Recurrent pregnancy (characterized by the presense of thin endometrium) loss using mesenchymal stem cells capable of differentiation in the endometrial-decidual direction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC | Experimental | Biological: Mesenchymal stem cells capable of differentiation in the endometrial-decidual direction, Other: Standard treatment according to the clinical protocolsExperimental: Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC |
| Standard treatment according to the clinical protocols | Active comparator | Other: Standard treatment according to the clinical protocolsStandard treatment of Recurrent Pregnancy Loss according to the clinical protocols |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- female patients of reproductive age 18-49 years;
- recurrent pregnancy loss without current pregnancy with thin endometrium;
- unsuccessful IVF cycles due to thin endometrium;
- endometrial thickness is ≤6 mm in the first and second phases of the menstrual cycle;
- uterine infertility associated with endometrial hypoplasia;
Key exclusion criteria (11 listed)
- patients with congenital malformations of the genital organs: agenesis and aplasia of the uterus, bicornuate uterus, unicornuate uterus, congenital fistula between the uterus and the digestive and urinary tracts, other congenital anomalies of the body and cervix. congenital anomaly of the body and cervix, unspecified, other specified developmental anomalies;
- acute inflammatory processes in the uterus;
- acute or chronic infectious and non-infectious diseases in the acute stage, including HIV, hepatitis B and C, syphilis, tuberculosis, chlamydia, myco-, ureaplasmosis, herpes, toxoplasmosis, rubella, cytomegalovirus, gonorrhea, trichomoniasis, etc.;
- autoimmune diseases;
- patients with malignant tumor including a history;
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 cells capable of differentiation in the endometrial-decidual directionMesenchymal stem cells capable of differentiation in the endometrial-decidual direction | Biological | Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC |
| Standard treatment according to the clinical protocolsStandard treatment of Recurrent Pregnancy Loss according to the clinical protocols | Other | Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC, Standard treatment according to the clinical protocols |
Primary outcome
Adverse effects associated with the therapy
Time frame: 1 year
Determination of adverse effects associated with the therapy
Adverse effects associated with the therapy
Time frame: 1 month
Determination of adverse effects associated with the therapy
Percent of patients with successful pregnancy
Time frame: 1 year
Percent of patients with successful pregnancy within 1 year after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- 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.
Andrei Hancharou, Dr study chair
Institute for biophysics and cellular engineering NAS of Belarus
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 capable of differentiation in the endometrial-decidual direction and Standard treatment according to the clinical protocols in people with Recurrent Pregnancy Loss, 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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 29 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna G Poleshko, Dr (+375295105774, renovacio888@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse effects associated with the therapy (time frame: 1 year). The study lists 3 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 29 Aug 2022.