Chronic Endometritis, Fallopian Tube Obstruction, Uterine Synechiae, Uterus; Scar
Conditions
Keywords
Fertility restoration, Mesenchymal stem cells
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.
Interventions
BIOLOGICALAutologous mesenchymal stem cells
Autologous adipose tissue-derived mesenchymal stem cells
OTHERstandard treatment
standard treatment according to clinical protocols
Sponsors
Belarusian Medical Academy of Post-Graduate Education
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of cured patients | 6 months | Number of patients cured |
| Number of patients with treatment-related adverse events | 4 weeks | MSC application related adverse events assessed by blood count, liver and function tests |
Countries
Belarus
Outcome results
None listed