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

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

Detailed Description
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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.

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

Conditions
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Allergic Rhinitis, Rhinosinusitis Chronic

Intervention / Treatment
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* Biological: Olfactory mucosa-derived mesenchymal stem cells
* Other: Standard treatment of type Allergic Rhinitis according to the clinical protocols
* Other: Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with allergic rhinitis receiving standard treatment and mesenchymal stem cells<br>Group 1: Patients with allergic rhinitis receiving standard treatment and olfactory mucosa-derived mesenchymal stem cells | Biological: Olfactory mucosa-derived mesenchymal stem cells<br>* Olfactory mucosa-derived mesenchymal stem cells<br>Other: Standard treatment of type Allergic Rhinitis according to the clinical protocols<br>* Standard treatment of type Allergic Rhinitis according to the clinical protocols<br>|
| Experimental: Patients with chronic rhinosinusitis receiving standard treatment and mesenchymal stem cells<br>Group 2: Patients with chronic polypous rhinosinusitis receiving standard treatment and olfactory mucosa-derived mesenchymal stem cells | Biological: Olfactory mucosa-derived mesenchymal stem cells<br>* Olfactory mucosa-derived mesenchymal stem cells<br>Other: Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols<br>* Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols<br>|
| Active Comparator: Patients with allergic rhinitis receiving standard treatment<br>Group 3: Patients with allergic rhinitis receiving standard treatment | Other: Standard treatment of type Allergic Rhinitis according to the clinical protocols<br>* Standard treatment of type Allergic Rhinitis according to the clinical protocols<br>|
| Active Comparator: Patients with chronic polypous rhinosinusitis receiving standard treatment<br>Group 4: Patients with chronic polypous rhinosinusitis receiving standard treatment | Other: Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols<br>* Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |