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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
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Endometritis focused on measuring Fertility restoration, Mesenchymal stem cells

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

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
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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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