Fertility Restoration Using Autologous Mesenchymal Stem Cells

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

Status and phase: Completed; Phase 2; Phase 1

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

Treatments: Other: standard treatment; Biological: Autologous mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04432467

IBCE_MSC(Fertility)

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

mesenchymal stem cells

Experimental group

Description:

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

Treatment:

Biological: Autologous mesenchymal stem cells

Other: standard treatment

control

Active Comparator group

Description:

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

Treatment:

Other: standard treatment