Treatment of Recurrent Pregnancy Loss Using Mesenchymal Stem Cells

Study Overview
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Brief Summary
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Treatment of Recurrent pregnancy loss using mesenchymal stem cells capable of differentiation in the endometrial-decidual direction.

Detailed Description
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Treatment of Recurrent pregnancy (characterized by the presense of thin endometrium) loss using mesenchymal stem cells capable of differentiation in the endometrial-decidual direction.

Official Title
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Treatment of Recurrent Pregnancy Loss Using Mesenchymal Stem Cells Capable of Differentiation in the Endometrial-decidual Direction

Conditions
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Recurrent Pregnancy Loss

Intervention / Treatment
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* Biological: Mesenchymal stem cells capable of differentiation in the endometrial-decidual direction
* Other: Standard treatment according to the clinical protocols


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC<br>Experimental: Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC | Biological: Mesenchymal stem cells capable of differentiation in the endometrial-decidual direction<br>* Mesenchymal stem cells capable of differentiation in the endometrial-decidual direction<br>Other: Standard treatment according to the clinical protocols<br>* Standard treatment of Recurrent Pregnancy Loss according to the clinical protocols<br>|
| Active Comparator: Standard treatment according to the clinical protocols<br>Standard treatment of Recurrent Pregnancy Loss according to the clinical protocols | Other: Standard treatment according to the clinical protocols<br>* Standard treatment of Recurrent Pregnancy Loss according to the clinical protocols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects associated with the therapy | Determination of adverse effects associated with the therapy | 1 year | 
| Adverse effects associated with the therapy | Determination of adverse effects associated with the therapy | 1 month | 
| Percent of patients with successful pregnancy | Percent of patients with successful pregnancy within 1 year after treatment | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent Pregnancy Loss, Mesenchymal stem cells