Treatment of Recurrent Pregnancy Loss Using Mesenchymal Stem Cells

NCT ID: NCT05520112

Last Updated: 2022-08-29

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-12-31

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.

Conditions

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Recurrent Pregnancy Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

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

Standard treatment according to the clinical protocols

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Standard treatment according to the clinical protocols

Intervention Type OTHER

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

Intervention Type BIOLOGICAL

Standard treatment according to the clinical protocols

Standard treatment of Recurrent Pregnancy Loss according to the clinical protocols

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Belarusian Medical Academy of Post-Graduate Education

OTHER

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Belarus

Central Contacts

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Anna G Poleshko, Dr

Role: CONTACT

+375295105774

Other Identifiers

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IBCE_MSC(Endometrial)

Identifier Type: -

Identifier Source: org_study_id

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