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| Name | Class |
|---|---|
| Belarusian Medical Academy of Post-Graduate Education | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mesenchymal stem cells | Experimental | 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 |
|
| control | Active Comparator | Patients with impending caesarean section or with chronic inflammation in the mucosa of the uterus and fallopian tubes receiving standard treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous mesenchymal stem cells | Biological | Autologous adipose tissue-derived mesenchymal stem cells |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Igor D Volotovski, Dr | Head of the Lab of Institute of Biophysics and Cell Engineering | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus | Minsk | 220072 | Belarus |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D006175 | Gynatresia |
| D005184 | Fallopian Tube Diseases |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005831 | Genital Diseases, Female |
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| standard treatment | Other | standard treatment according to clinical protocols |
|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D000291 | Adnexal Diseases |