Treatment of Recurrent Pregnancy Loss Using Mesenchymal Stem Cells
Primary Purpose
Recurrent Pregnancy Loss
Status
Not yet recruiting
Phase
Phase 1
Locations
Belarus
Study Type
Interventional
Intervention
Mesenchymal stem cells capable of differentiation in the endometrial-decidual direction
Standard treatment according to the clinical protocols
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Pregnancy Loss focused on measuring Recurrent Pregnancy Loss, Mesenchymal stem cells
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.
Sites / Locations
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC
Standard treatment according to the clinical protocols
Arm Description
Experimental: Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC
Standard treatment of Recurrent Pregnancy Loss according to the clinical protocols
Outcomes
Primary Outcome Measures
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Percent of patients with successful pregnancy
Percent of patients with successful pregnancy within 1 year after treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT05520112
First Posted
August 26, 2022
Last Updated
August 26, 2022
Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Belarusian Medical Academy of Post-Graduate Education
1. Study Identification
Unique Protocol Identification Number
NCT05520112
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Belarusian Medical Academy of Post-Graduate Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Pregnancy Loss
Keywords
Recurrent Pregnancy Loss, Mesenchymal stem cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC
Arm Type
Experimental
Arm Description
Experimental: Patients with Recurrent Pregnancy Loss receiving standard treatment and autologous MSC
Arm Title
Standard treatment according to the clinical protocols
Arm Type
Active Comparator
Arm Description
Standard treatment of Recurrent Pregnancy Loss according to the clinical protocols
Intervention Type
Biological
Intervention Name(s)
Mesenchymal stem cells capable of differentiation in the endometrial-decidual direction
Intervention Description
Mesenchymal stem cells capable of differentiation in the endometrial-decidual direction
Intervention Type
Other
Intervention Name(s)
Standard treatment according to the clinical protocols
Intervention Description
Standard treatment of Recurrent Pregnancy Loss according to the clinical protocols
Primary Outcome Measure Information:
Title
Adverse effects associated with the therapy
Description
Determination of adverse effects associated with the therapy
Time Frame
1 year
Title
Adverse effects associated with the therapy
Description
Determination of adverse effects associated with the therapy
Time Frame
1 month
Title
Percent of patients with successful pregnancy
Description
Percent of patients with successful pregnancy within 1 year after treatment
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna G Poleshko, Dr
Phone
+375295105774
Email
renovacio888@yandex.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei Hancharou, Dr
Organizational Affiliation
Institute for biophysics and cellular engineering NAS of Belarus
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
City
Minsk
ZIP/Postal Code
220072
Country
Belarus
12. IPD Sharing Statement
Plan to Share IPD
No
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Treatment of Recurrent Pregnancy Loss Using Mesenchymal Stem Cells
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