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Completed

NCT Number: NCT04432467

Fertility Restoration Using Autologous Mesenchymal Stem Cells

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

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Key information

Conditions

Chronic Endometritis Adnexal Diseases Cicatrix Fallopian Tube Diseases Fallopian Tube Obstruction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Genital Diseases Genital Diseases, Female Gynatresia Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Synechiae Uterus; Scar

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Minsk, 220072, Belarus

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous mesenchymal stem cells

Biological

Autologous adipose tissue-derived mesenchymal stem cells

standard treatment

Other

standard treatment according to clinical protocols

Primary outcomes

  1. Number of cured patients

    Time frame: 6 months

    Number of patients cured

  2. Number of patients with treatment-related adverse events

    Time frame: 4 weeks

    MSC application related adverse events assessed by blood count, liver and function tests

Sponsors and collaborators

Lead sponsor

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

Other Gov

Collaborators

  • Belarusian Medical Academy of Post-Graduate Education

Registry information

Official study title

Fertility Restoration Using Autologous Adipose Tissue Derived Mesenchymal Stem Cells

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 16, 2020
Registry last updated
Dec 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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