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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05167552
• Other study ID #: IBCE_AllRhin
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: March 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2022
• Source: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
• Contact: Natalia Antonevich, Dr
• Phone: +375173691763
• Email: antonevich.n[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic
• Rhinosinusitis Chronic
• Sinusitis

Intervention

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
• Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols
Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

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