Treatment of Recurrent Pregnancy Loss Using Mesenchymal Stem Cells
NCT ID: NCT05520112
Last Updated: 2022-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2022-11-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC
Experimental: Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC
Mesenchymal stem cells capable of differentiation in the endometrial-decidual direction
Mesenchymal stem cells capable of differentiation in the endometrial-decidual direction
Standard treatment according to the clinical protocols
Standard treatment of Recurrent Pregnancy Loss according to the clinical protocols
Standard treatment according to the clinical protocols
Standard treatment of Recurrent Pregnancy Loss according to the clinical protocols
Standard treatment according to the clinical protocols
Standard treatment of Recurrent Pregnancy Loss according to the clinical protocols
Interventions
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Mesenchymal stem cells capable of differentiation in the endometrial-decidual direction
Mesenchymal stem cells capable of differentiation in the endometrial-decidual direction
Standard treatment according to the clinical protocols
Standard treatment of Recurrent Pregnancy Loss according to the clinical protocols
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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;
* 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.
18 Years
49 Years
FEMALE
No
Sponsors
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Belarusian Medical Academy of Post-Graduate Education
OTHER
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
OTHER_GOV
Responsible Party
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Principal Investigators
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Andrei Hancharou, Dr
Role: STUDY_CHAIR
Institute for biophysics and cellular engineering NAS of Belarus
Locations
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Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Minsk, , Belarus
Countries
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Central Contacts
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Other Identifiers
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IBCE_MSC(Endometrial)
Identifier Type: -
Identifier Source: org_study_id
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