Fertility Restoration Using Autologous Mesenchymal Stem Cells

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus10 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Endometritis Uterus; Scar Uterine Synechiae Fallopian Tube Obstruction

Interventions

Autologous mesenchymal stem cellsBIOLOGICAL

Autologous adipose tissue-derived mesenchymal stem cells

standard treatmentOTHER

standard treatment according to clinical protocols

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Minsk, Belarus

Outcomes

Primary Outcomes

Number of cured patients

Number of patients cured

Time frame: 6 months

Number of patients with treatment-related adverse events

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

Time frame: 4 weeks

Data from ClinicalTrials.gov

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