Allergic Rhinitis, Rhinosinusitis Chronic
Conditions
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.
Interventions
Olfactory mucosa-derived mesenchymal stem cells
OTHERStandard treatment of type Allergic Rhinitis according to the clinical protocols
Standard treatment of type Allergic Rhinitis according to the clinical protocols
OTHERStandard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols
Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols
Sponsors
The Republican Center for Research and Practice in Otolaryngology
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The relapse-free period | 6 month | 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 | 6 month | The need for the use of basic drug therapy |
| Adverse effects associated with the therapy | 1 month | Determination of adverse effects associated with the therapy |
Contacts
Primary ContactNatalia Antonevich, Dr
Backup ContactAndrei Hancharou, Dr
Outcome results
None listed