Treatment of Allergic Rhinitis and Chronic Polypous Rhinosinusitis With Olfactory Mucosa-derived Mesenchymal Stem Cells
NCT ID: NCT05167552
Last Updated: 2022-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2022-03-01
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
NCT03122795
Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps
NCT01732536
An Open-label Study to Identify Molecular Markers of Steroid Resistance
NCT01616160
Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps
NCT07187583
Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis (CRS).
NCT07184684
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Olfactory mucosa-derived mesenchymal stem cells
Olfactory mucosa-derived mesenchymal stem cells
Standard treatment of type Allergic Rhinitis according to the clinical protocols
Standard treatment of type Allergic Rhinitis according to the clinical protocols
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
Olfactory mucosa-derived mesenchymal stem cells
Olfactory mucosa-derived mesenchymal stem cells
Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols
Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols
Patients with allergic rhinitis receiving standard treatment
Group 3: Patients with allergic rhinitis receiving standard treatment
Standard treatment of type Allergic Rhinitis according to the clinical protocols
Standard treatment of type Allergic Rhinitis according to the clinical protocols
Patients with chronic polypous rhinosinusitis receiving standard treatment
Group 4: Patients with chronic polypous rhinosinusitis receiving standard treatment
Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols
Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Olfactory mucosa-derived mesenchymal stem cells
Olfactory mucosa-derived mesenchymal stem cells
Standard treatment of type Allergic Rhinitis according to the clinical protocols
Standard treatment of type Allergic Rhinitis according to the clinical protocols
Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols
Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
* Written informed consent
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Republican Center for Research and Practice in Otolaryngology
UNKNOWN
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Natalia Antonevich, Dr
Role: STUDY_DIRECTOR
the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Yulia Eremenko, Prof
Role: STUDY_DIRECTOR
The Republican Center for Research and Practice in Otolaryngology
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IBCE_AllRhin
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.