Fertility Restoration Using Autologous Mesenchymal Stem Cells

Chronic Endometritis Clinical Trial

Official title:

Fertility Restoration Using Autologous Adipose Tissue Derived Mesenchymal Stem Cells

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04432467
• Other study ID #: IBCE_MSC(Fertility)
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 1, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: December 2021
• Source: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Endometritis
• Endometritis
• Fallopian Tube Obstruction
• Uterine Synechiae
• Uterus; Scar

Intervention

Biological:
• Autologous mesenchymal stem cells
Autologous adipose tissue-derived mesenchymal stem cells

Other:
• standard treatment
standard treatment according to clinical protocols

Locations

Country	Name	City	State
Belarus	Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus	Minsk

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus	Belarusian Medical Academy of Post-Graduate Education

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cured patients	Number of patients cured	6 months
Primary	Number of patients with treatment-related adverse events	MSC application related adverse events assessed by blood count, liver and function tests	4 weeks