Clinical trial NCT05520112: Treatment of Recurrent Pregnancy Loss Using Mesenchymal Stem Cells
Official title: Treatment of Recurrent Pregnancy Loss Using Mesenchymal Stem Cells Capable of Differentiation in the Endometrial-decidual Direction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Recurrent Pregnancy Loss
Keywords: Recurrent Pregnancy Loss, Mesenchymal stem cells
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
Collaborators: name: Belarusian Medical Academy of Post-Graduate Education
First posted: 2022-08-29
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse effects associated with the therapy
timeFrame: 1 year
measure: Adverse effects associated with the therapy
timeFrame: 1 month
measure: Percent of patients with successful pregnancy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study officials:
affiliation: Institute for biophysics and cellular engineering NAS of Belarus
name: Andrei Hancharou, Dr
role: STUDY_CHAIR
References: