Fertility Restoration Using Autologous Mesenchymal Stem Cells

Phase 1

Completed

• Conditions: Uterus; Scar; Chronic Endometritis; Fallopian Tube Obstruction; Uterine Synechiae
• Interventions: Other: standard treatment; Biological: Autologous mesenchymal stem cells

• Registration Number: NCT04432467
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

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.

Study Timeline

• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-16
• Study Start: 2020-10-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	standard treatment	Patients with impending caesarean section or with chronic inflammation in the mucosa of the uterus and fallopian tubes receiving standard treatment
mesenchymal stem cells	Autologous mesenchymal stem cells	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
mesenchymal stem cells	standard treatment	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

Primary Outcome Measures

Name	Time	Method
Number of patients with treatment-related adverse events	4 weeks	MSC application related adverse events assessed by blood count, liver and function tests
Number of cured patients	6 months	Number of patients cured

Trial Locations

Locations (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus; 🇧🇾 Minsk, Belarus