Fertility Restoration Using Autologous Mesenchymal Stem Cells

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fertility Restoration Using Autologous Adipose Tissue Derived Mesenchymal Stem Cells

Conditions
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Chronic Endometritis, Uterus; Scar, Uterine Synechiae, Fallopian Tube Obstruction

Intervention / Treatment
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* Biological: Autologous mesenchymal stem cells
* Other: standard treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mesenchymal stem cells<br>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 | Biological: Autologous mesenchymal stem cells<br>* Autologous adipose tissue-derived mesenchymal stem cells<br>Other: standard treatment<br>* standard treatment according to clinical protocols<br>|
| Active Comparator: control<br>Patients with impending caesarean section or with chronic inflammation in the mucosa of the uterus and fallopian tubes receiving standard treatment | Other: standard treatment<br>* standard treatment according to clinical protocols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cured patients | Number of patients cured | 6 months | 
| Number of patients with treatment-related adverse events | MSC application related adverse events assessed by blood count, liver and function tests | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fertility restoration, Mesenchymal stem cells