Treatment of Recurrent Pregnancy Loss Using Mesenchymal Stem Cells

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Recurrent Pregnancy Loss

Treatments: Biological: Mesenchymal stem cells capable of differentiation in the endometrial-decidual direction; Other: Standard treatment according to the clinical protocols

Study type: Interventional

Funder types: Other

Identifiers

NCT05520112

IBCE_MSC(Endometrial)

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC

Experimental group

Description:

Experimental: Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC

Treatment:

Other: Standard treatment according to the clinical protocols

Biological: Mesenchymal stem cells capable of differentiation in the endometrial-decidual direction

Standard treatment according to the clinical protocols

Active Comparator group

Description:

Standard treatment of Recurrent Pregnancy Loss according to the clinical protocols

Treatment:

Other: Standard treatment according to the clinical protocols