NCT05520112

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

1.2 years

First QC Date

August 26, 2022

Last Update Submit

August 26, 2022

Conditions

Recurrent Pregnancy Loss

Keywords

Recurrent Pregnancy Loss, Mesenchymal stem cells

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC

EXPERIMENTAL

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

Biological: Mesenchymal stem cells capable of differentiation in the endometrial-decidual directionOther: Standard treatment according to the clinical protocols

Standard treatment according to the clinical protocols

ACTIVE COMPARATOR

Standard treatment of Recurrent Pregnancy Loss according to the clinical protocols

Other: Standard treatment according to the clinical protocols

Interventions

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

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

Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC
Standard treatment according to the clinical protocolsOTHER

Standard treatment of Recurrent Pregnancy Loss according to the clinical protocols

Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSCStandard treatment according to the clinical protocols

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Minsk, 220072, Belarus

Location

Study Officials

  • Andrei Hancharou, Dr

    Institute for biophysics and cellular engineering NAS of Belarus

    STUDY CHAIR

Central Study Contacts

Anna G Poleshko, Dr

CONTACT

+375295105774renovacio888@yandex.ru

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2022

First Posted

August 29, 2022

Study Start

November 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 29, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)