Status:

COMPLETED

Fertility Restoration Using Autologous Mesenchymal Stem Cells

Lead Sponsor:

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Collaborating Sponsors:

Belarusian Medical Academy of Post-Graduate Education

Conditions:

Chronic Endometritis

Uterus; Scar

Eligibility:

FEMALE

18-45 years

Phase:

PHASE1

PHASE2

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 occurren...

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 preventi...

Eligibility Criteria

Inclusion

  • chronic endometritis
  • postoperative uterus scars
  • uterine synechia
  • fallopian tube obstruction
  • absence of acute inflammation in the uterus

Exclusion

  • 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.

Key Trial Info

Start Date :

October 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 30 2021

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT04432467

Start Date

October 1 2020

End Date

September 30 2021

Last Update

December 10 2021

Active Locations (1)

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Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Minsk, Belarus, 220072