Allergic Rhinitis Clinical Trial
Official title:
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
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus | The Republican Center for Research and Practice in Otolaryngology |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The relapse-free period | The duration of the relapse-free period | 6 month | |
Primary | The relapse-free period | The duration of the relapse-free period | 1 year | |
Primary | The need for surgical intervention | The need for surgical intervention | 1 year | |
Primary | The need for the use of basic drug therapy | The need for the use of basic drug therapy | 6 month | |
Primary | The need for the use of basic drug therapy | The need for the use of basic drug therapy | 1 year | |
Primary | Adverse effects associated with the therapy | Determination of adverse effects associated with the therapy | 1 month | |
Primary | Adverse effects associated with the therapy | Determination of adverse effects associated with the therapy | 1 year |
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