Fertility Restoration Using Autologous Mesenchymal Stem Cells
Primary Purpose
Chronic Endometritis, Uterus; Scar, Uterine Synechiae
Status
Completed
Phase
Phase 1
Locations
Belarus
Study Type
Interventional
Intervention
Autologous mesenchymal stem cells
standard treatment
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Endometritis focused on measuring Fertility restoration, Mesenchymal stem cells
Eligibility Criteria
Inclusion Criteria:
- chronic endometritis
- postoperative uterus scars
- uterine synechia
- fallopian tube obstruction
- absence of acute inflammation in the uterus
Exclusion Criteria:
- Patients with genetic diseases of muscle and connective tissue;
- Patients with malformations of the uterus;
- Acute and chronic infectious diseases: HIV, mycoplasma infection, hepatitis B and C, syphilis; autoimmune diseases; oncological diseases; continuous hormonal therapy with cytostatics corticosteroids; acute noncommunicable diseases;
- mental disorders;
- Drug or alcohol addiction;
- Benign tumors of uterus and appendages;
- Hypersensitivity to any component of the studied biomedical cell product.
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
mesenchymal stem cells
control
Arm Description
Patients with impending caesarean section or with chronic inflammation in the mucosa of the uterus and fallopian tubes receiving standard treatment and mesenchymal stem cells
Patients with impending caesarean section or with chronic inflammation in the mucosa of the uterus and fallopian tubes receiving standard treatment
Outcomes
Primary Outcome Measures
Number of cured patients
Number of patients cured
Number of patients with treatment-related adverse events
MSC application related adverse events assessed by blood count, liver and function tests
Secondary Outcome Measures
Full Information
NCT ID
NCT04432467
First Posted
June 11, 2020
Last Updated
December 9, 2021
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
NCT04432467
Brief Title
Fertility Restoration Using Autologous Mesenchymal Stem Cells
Official Title
Fertility Restoration Using Autologous Adipose Tissue Derived Mesenchymal Stem Cells
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
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 the patients with scarring and adhesions in the uterus resulting from caesarean section or chronic inflammation in the mucosa of the uterus and fallopian tubes and preventing the occurrence of these effects in the future
Detailed Description
The aim of the project is to develop a biomedical cell product based on autologous adipose tissue derived mesenchymal stem cells and a biodegradable carrier for highly effective treatment and prevention of scarring and adhesions in the uterus acquired as a result of cesarean section or chronic inflammatory processes in the uterine mucosa and fallopian tubes; to conduct the clinical trials of the biomedical cell product in the treatment of uterus scarring and infertility in women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Endometritis, Uterus; Scar, Uterine Synechiae, Fallopian Tube Obstruction
Keywords
Fertility restoration, 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
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mesenchymal stem cells
Arm Type
Experimental
Arm Description
Patients with impending caesarean section or with chronic inflammation in the mucosa of the uterus and fallopian tubes receiving standard treatment and mesenchymal stem cells
Arm Title
control
Arm Type
Active Comparator
Arm Description
Patients with impending caesarean section or with chronic inflammation in the mucosa of the uterus and fallopian tubes receiving standard treatment
Intervention Type
Biological
Intervention Name(s)
Autologous mesenchymal stem cells
Intervention Description
Autologous adipose tissue-derived mesenchymal stem cells
Intervention Type
Other
Intervention Name(s)
standard treatment
Intervention Description
standard treatment according to clinical protocols
Primary Outcome Measure Information:
Title
Number of cured patients
Description
Number of patients cured
Time Frame
6 months
Title
Number of patients with treatment-related adverse events
Description
MSC application related adverse events assessed by blood count, liver and function tests
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic endometritis
postoperative uterus scars
uterine synechia
fallopian tube obstruction
absence of acute inflammation in the uterus
Exclusion Criteria:
Patients with genetic diseases of muscle and connective tissue;
Patients with malformations of the uterus;
Acute and chronic infectious diseases: HIV, mycoplasma infection, hepatitis B and C, syphilis; autoimmune diseases; oncological diseases; continuous hormonal therapy with cytostatics corticosteroids; acute noncommunicable diseases;
mental disorders;
Drug or alcohol addiction;
Benign tumors of uterus and appendages;
Hypersensitivity to any component of the studied biomedical cell product.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Igor D Volotovski, Dr
Organizational Affiliation
Head of the Lab of Institute of Biophysics and Cell Engineering
Official's Role
Study Director
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
Learn more about this trial
Fertility Restoration Using Autologous Mesenchymal Stem Cells
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