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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Allergic Rhinitis; Rhinosinusitis Chronic
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
• Collaborators: The Republican Center for Research and Practice in Otolaryngology
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: IBCE_AllRhin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No