NCT04432467

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

December 10, 2021

Status Verified

December 1, 2021

Enrollment Period

12 months

First QC Date

June 11, 2020

Last Update Submit

December 9, 2021

Conditions

Chronic EndometritisUterus; ScarUterine SynechiaeFallopian Tube Obstruction

Keywords

Fertility restorationMesenchymal stem cells

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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

Biological: Autologous mesenchymal stem cellsOther: standard treatment

control

ACTIVE COMPARATOR

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

Other: standard treatment

Interventions

Autologous mesenchymal stem cellsBIOLOGICAL

Autologous adipose tissue-derived mesenchymal stem cells

mesenchymal stem cells
standard treatmentOTHER

standard treatment according to clinical protocols

controlmesenchymal stem cells

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • chronic endometritis
  • postoperative uterus scars
  • uterine synechia
  • fallopian tube obstruction
  • absence of acute inflammation in the uterus

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Minsk, 220072, Belarus

Location

MeSH Terms

Conditions

CicatrixGynatresiaFallopian Tube Diseases

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesAdnexal Diseases

Study Officials

  • Igor D Volotovski, Dr

    Head of the Lab of Institute of Biophysics and Cell Engineering

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 16, 2020

Study Start

October 1, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

December 10, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)