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Fertility Restoration Using Autologous Mesenchymal Stem Cells

NCT ID: NCT04432467

Last Updated: 2021-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-09-30

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.

Conditions

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Chronic Endometritis Uterus; Scar Uterine Synechiae Fallopian Tube Obstruction

Keywords

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Fertility restoration Mesenchymal stem cells

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Autologous mesenchymal stem cells

Intervention Type BIOLOGICAL

Autologous adipose tissue-derived mesenchymal stem cells

standard treatment

Intervention Type OTHER

standard treatment according to clinical protocols

control

Patients with impending caesarean section or with chronic inflammation in the mucosa of the uterus and fallopian tubes receiving standard treatment

Group Type ACTIVE_COMPARATOR

standard treatment

Intervention Type OTHER

standard treatment according to clinical protocols

Interventions

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Autologous mesenchymal stem cells

Autologous adipose tissue-derived mesenchymal stem cells

Intervention Type BIOLOGICAL

standard treatment

standard treatment according to clinical protocols

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Belarusian Medical Academy of Post-Graduate Education

OTHER

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Igor D Volotovski, Dr

Role: STUDY_DIRECTOR

Head of the Lab of Institute of Biophysics and Cell Engineering

Locations

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

Minsk, , Belarus

Site Status

Countries

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Belarus

Other Identifiers

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IBCE_MSC(Fertility)

Identifier Type: -

Identifier Source: org_study_id