Treatment of Recurrent Pregnancy Loss Using Mesenchymal Stem Cells

Recurrent Pregnancy Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05520112
• Other study ID #: IBCE_MSC(Endometrial)
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: November 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
• Contact: Anna G Poleshko, Dr
• Phone: +375295105774
• Email: renovacio888[@]yandex.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Fetal Death
• Recurrence
• Recurrent Pregnancy Loss

Intervention

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

Other:
• Standard treatment according to the clinical protocols
Standard treatment of Recurrent Pregnancy Loss according to the clinical protocols

Locations

Country	Name	City	State
Belarus	Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus	Minsk

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus	Belarusian Medical Academy of Post-Graduate Education

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse effects associated with the therapy	Determination of adverse effects associated with the therapy	1 year
Primary	Adverse effects associated with the therapy	Determination of adverse effects associated with the therapy	1 month
Primary	Percent of patients with successful pregnancy	Percent of patients with successful pregnancy within 1 year after treatment	1 year