Treatment of Allergic Rhinitis and Chronic Polypous Rhinosinusitis With Olfactory Mucosa-derived Mesenchymal Stem Cells

Phase 1

• Conditions: Allergic Rhinitis; Rhinosinusitis Chronic
• Interventions: Biological: Olfactory mucosa-derived mesenchymal stem cells; Other: Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols; Other: Standard treatment of type Allergic Rhinitis according to the clinical protocols

• Registration Number: NCT05167552
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Brief Summary

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

Detailed Description

During the implementation of the project, the methods for the treatment of allergic rhinitis and chronic polypous rhinosinusitis with olfactory mucosa-derived mesenchymal stem cells will be developed.

The positive outlook for the effectiveness of MSCs is due to the following:

* knowledge of the leading role of immunopathogenetic mechanisms in the development of allergic rhinitis and chronic polypous rhinosinusitis and the pronounced immunomodulating properties of MSCs;

* the ability of MSCs to reduce the production of proinflammatory cytokines and suppress immune inflammation;

* positive results of preclinical studies of the method of treatment of diseases accompanied by over-activation of the immune system, including autoimmune diseases, in animals and the first clinical studies in patients.

Study Timeline

• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-22
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-18
• Last Update Posted: 2022-01-19
• Study Start: 2022-03-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with allergic rhinitis receiving standard treatment and mesenchymal stem cells	Standard treatment of type Allergic Rhinitis according to the clinical protocols	Group 1: Patients with allergic rhinitis receiving standard treatment and olfactory mucosa-derived mesenchymal stem cells
Patients with allergic rhinitis receiving standard treatment and mesenchymal stem cells	Olfactory mucosa-derived mesenchymal stem cells	Group 1: Patients with allergic rhinitis receiving standard treatment and olfactory mucosa-derived mesenchymal stem cells
Patients with chronic rhinosinusitis receiving standard treatment and mesenchymal stem cells	Olfactory mucosa-derived mesenchymal stem cells	Group 2: Patients with chronic polypous rhinosinusitis receiving standard treatment and olfactory mucosa-derived mesenchymal stem cells
Patients with allergic rhinitis receiving standard treatment	Standard treatment of type Allergic Rhinitis according to the clinical protocols	Group 3: Patients with allergic rhinitis receiving standard treatment
Patients with chronic polypous rhinosinusitis receiving standard treatment	Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols	Group 4: Patients with chronic polypous rhinosinusitis receiving standard treatment
Patients with chronic rhinosinusitis receiving standard treatment and mesenchymal stem cells	Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols	Group 2: Patients with chronic polypous rhinosinusitis receiving standard treatment and olfactory mucosa-derived mesenchymal stem cells

Primary Outcome Measures

Name	Time	Method
The relapse-free period	1 year	The duration of the relapse-free period
The need for surgical intervention	1 year	The need for surgical intervention
The need for the use of basic drug therapy	1 year	The need for the use of basic drug therapy
Adverse effects associated with the therapy	1 year	Determination of adverse effects associated with the therapy