NCT05167552

Brief Summary

Treatment of patients with allergic rhinitis and chronic polypous rhinosinusitis with olfactory mucosa-derived mesenchymal stem cells

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2022

Status
unknown

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

November 29, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

1.8 years

First QC Date

November 29, 2021

Last Update Submit

January 18, 2022

Conditions

Allergic RhinitisRhinosinusitis Chronic

Outcome Measures

Primary Outcomes (7)

  • The relapse-free period

    The duration of the relapse-free period

    6 month

  • The relapse-free period

    The duration of the relapse-free period

    1 year

  • The need for surgical intervention

    The need for surgical intervention

    1 year

  • The need for the use of basic drug therapy

    The need for the use of basic drug therapy

    6 month

  • The need for the use of basic drug therapy

    The need for the use of basic drug therapy

    1 year

  • Adverse effects associated with the therapy

    Determination of adverse effects associated with the therapy

    1 month

  • Adverse effects associated with the therapy

    Determination of adverse effects associated with the therapy

    1 year

Study Arms (4)

Patients with allergic rhinitis receiving standard treatment and mesenchymal stem cells

EXPERIMENTAL

Group 1: Patients with allergic rhinitis receiving standard treatment and olfactory mucosa-derived mesenchymal stem cells

Biological: Olfactory mucosa-derived mesenchymal stem cellsOther: Standard treatment of type Allergic Rhinitis according to the clinical protocols

Patients with chronic rhinosinusitis receiving standard treatment and mesenchymal stem cells

EXPERIMENTAL

Group 2: Patients with chronic polypous rhinosinusitis receiving standard treatment and olfactory mucosa-derived mesenchymal stem cells

Biological: Olfactory mucosa-derived mesenchymal stem cellsOther: Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols

Patients with allergic rhinitis receiving standard treatment

ACTIVE COMPARATOR

Group 3: Patients with allergic rhinitis receiving standard treatment

Other: Standard treatment of type Allergic Rhinitis according to the clinical protocols

Patients with chronic polypous rhinosinusitis receiving standard treatment

ACTIVE COMPARATOR

Group 4: Patients with chronic polypous rhinosinusitis receiving standard treatment

Other: Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols

Interventions

Olfactory mucosa-derived mesenchymal stem cellsBIOLOGICAL

Olfactory mucosa-derived mesenchymal stem cells

Patients with allergic rhinitis receiving standard treatment and mesenchymal stem cellsPatients with chronic rhinosinusitis receiving standard treatment and mesenchymal stem cells
Standard treatment of type Allergic Rhinitis according to the clinical protocolsOTHER

Standard treatment of type Allergic Rhinitis according to the clinical protocols

Patients with allergic rhinitis receiving standard treatmentPatients with allergic rhinitis receiving standard treatment and mesenchymal stem cells
Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocolsOTHER

Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols

Patients with chronic polypous rhinosinusitis receiving standard treatmentPatients with chronic rhinosinusitis receiving standard treatment and mesenchymal stem cells

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of allergic rhinitis or chronic polyposis rhinosinusitis
  • The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
  • Written informed consent

You may not qualify if:

  • The presence of any malignant tumor within the last 5 years
  • Acute or chronic diseases in the stage of decompensation
  • Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
  • Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods
  • Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
  • Patients are unable or unwilling to give written informed consent and / or follow research procedures
  • Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Natalia Antonevich, Dr

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

    STUDY DIRECTOR

  • Yulia Eremenko, Prof

    The Republican Center for Research and Practice in Otolaryngology

    STUDY DIRECTOR

Central Study Contacts

Natalia Antonevich, Dr

CONTACT

+375173691763antonevich.n@gmail.com

Andrei Hancharou, Dr

CONTACT

+375296248972hancharou@ibp.org.by

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

November 29, 2021

First Posted

December 22, 2021

Study Start

March 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share