Treatment of Recurrent Pregnancy Loss Using Mesenchymal Stem Cells
Phase 1
- Conditions
- Recurrent Pregnancy Loss
- Interventions
- Biological: Mesenchymal stem cells capable of differentiation in the endometrial-decidual directionOther: Standard treatment according to the clinical protocols
- Registration Number
- NCT05520112
- Brief Summary
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 20
Inclusion Criteria
- 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.
Exclusion Criteria
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC Standard treatment according to the clinical protocols Experimental: Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC Mesenchymal stem cells capable of differentiation in the endometrial-decidual direction Experimental: Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC Standard treatment according to the clinical protocols Standard treatment according to the clinical protocols Standard treatment of Recurrent Pregnancy Loss according to the clinical protocols
- Primary Outcome Measures
Name Time Method Adverse effects associated with the therapy 1 month Determination of adverse effects associated with the therapy
Percent of patients with successful pregnancy 1 year Percent of patients with successful pregnancy within 1 year after treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
🇧🇾Minsk, Belarus