Treatment of Recurrent Pregnancy Loss Using Mesenchymal Stem Cells

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Recurrent Pregnancy Loss
• Intervention / Treatment: Biological: Mesenchymal stem cells capable of differentiation in the endometrial-decidual direction; Other: Standard treatment according to the clinical protocols

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Anna G Poleshko, Dr; Phone Number: +375295105774; Email: renovacio888@yandex.ru

Study Locations

• Belarus
  • Minsk, Belarus, 220072
    • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 47 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC; Experimental: Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC	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
Active Comparator: Standard treatment according to the clinical protocols; Standard treatment of Recurrent Pregnancy Loss according to the clinical protocols	Other: Standard treatment according to the clinical protocols; Standard treatment of Recurrent Pregnancy Loss according to the clinical protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects associated with the therapy	Determination of adverse effects associated with the therapy	1 month
Adverse effects associated with the therapy	Determination of adverse effects associated with the therapy	1 year
Percent of patients with successful pregnancy	Percent of patients with successful pregnancy within 1 year after treatment	1 year

Collaborators and Investigators

• Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
• Collaborators: Belarusian Medical Academy of Post-Graduate Education
• Investigators: Study Chair: Andrei Hancharou, Dr, Institute for biophysics and cellular engineering NAS of Belarus

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 26, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Recurrent Pregnancy Loss, Mesenchymal stem cells
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pregnancy Complications; Death; Recurrence; Abortion, Spontaneous; Abortion, Habitual; Fetal Death
• Other Study ID Numbers: IBCE_MSC(Endometrial)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No