Clinical trial NCT05167552: Treatment of Allergic Rhinitis and Chronic Polypous Rhinosinusitis With Olfactory Mucosa-derived Mesenchymal Stem Cells
Official title: Treatment of Patients With Allergic Rhinitis and Chronic Polypous Rhinosinusitis With Olfactory Mucosa-derived Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Allergic Rhinitis
Rhinosinusitis Chronic
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
Collaborators: name: The Republican Center for Research and Practice in Otolaryngology
First posted: 2021-12-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The relapse-free period
timeFrame: 6 month
measure: The relapse-free period
timeFrame: 1 year
measure: The need for surgical intervention
timeFrame: 1 year
measure: The need for the use of basic drug therapy
timeFrame: 6 month
measure: The need for the use of basic drug therapy
timeFrame: 1 year
measure: Adverse effects associated with the therapy
timeFrame: 1 month
measure: Adverse effects associated with the therapy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
name: Natalia Antonevich, Dr
role: STUDY_DIRECTOR
affiliation: The Republican Center for Research and Practice in Otolaryngology
name: Yulia Eremenko, Prof
role: STUDY_DIRECTOR
References: