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Allergic RhinitisPhase 1/2NCT05167552

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

A Phase 1/2 study testing Olfactory mucosa-derived mesenchymal stem cells, Standard treatment of type Allergic Rhinitis according to the clinical protocols and Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols in people with Allergic Rhinitis and Rhinosinusitis Chronic, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Treatment of patients with allergic rhinitis and chronic polypous rhinosinusitis with olfactory mucosa-derived mesenchymal stem cells Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Allergic Rhinitis, Rhinosinusitis Chronic
What is being tested?
Olfactory mucosa-derived mesenchymal stem cells, Standard treatment of type Allergic Rhinitis according to the clinical protocols and Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Mar 2022to 31 Dec 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Natalia Antonevich, Dr contact

+375173691763

antonevich.n@gmail.com

Andrei Hancharou, Dr contact

+375296248972

hancharou@ibp.org.by

About this study

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

Read the 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.
Being tested
Olfactory mucosa-derived mesenchymal stem cells, Standard treatment of type Allergic Rhinitis according to the clinical protocols, Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols
Medical subject headings
Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Olfactory mucosa-derived mesenchymal stem cellsBiological

    Olfactory mucosa-derived mesenchymal stem cells

  • Standard treatment of type Allergic Rhinitis according to the clinical protocolsOther

    Standard treatment of type Allergic Rhinitis according to the clinical protocols

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

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

Study groups in NCT05167552
Study groupRoleWhat they receive
Patients with allergic rhinitis receiving standard treatment and mesenchymal stem cellsExperimentalGroup 1: Patients with allergic rhinitis receiving standard treatment and olfactory mucosa-derived mesenchymal stem cells
Receives: Biological: Olfactory mucosa-derived mesenchymal stem cells; Other: Standard treatment of type Allergic Rhinitis according to the clinical protocols
Patients with chronic rhinosinusitis receiving standard treatment and mesenchymal stem cellsExperimentalGroup 2: Patients with chronic polypous rhinosinusitis receiving standard treatment and olfactory mucosa-derived mesenchymal stem cells
Receives: Biological: Olfactory mucosa-derived mesenchymal stem cells; Other: Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols
Patients with allergic rhinitis receiving standard treatmentActive comparatorGroup 3: Patients with allergic rhinitis receiving standard treatment
Receives: Other: Standard treatment of type Allergic Rhinitis according to the clinical protocols
Patients with chronic polypous rhinosinusitis receiving standard treatmentActive comparatorGroup 4: Patients with chronic polypous rhinosinusitis receiving standard treatment
Receives: Other: Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The relapse-free period

    The duration of the relapse-free period

    Measured: 6 month

  2. The relapse-free period

    The duration of the relapse-free period

    Measured: 1 year

  3. The need for surgical intervention

    The need for surgical intervention

    Measured: 1 year

  4. The need for the use of basic drug therapy

    The need for the use of basic drug therapy

    Measured: 6 month

  5. The need for the use of basic drug therapy

    The need for the use of basic drug therapy

    Measured: 1 year

  6. Adverse effects associated with the therapy

    Determination of adverse effects associated with the therapy

    Measured: 1 month

  7. Adverse effects associated with the therapy

    Determination of adverse effects associated with the therapy

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2021
  2. Study start1 Mar 2022 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05167552
Sponsor's protocol ID
IBCE_AllRhin
Status last verified
Jan 2022
First submitted
29 Nov 2021
Last updated
19 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Olfactory mucosa-derived mesenchymal stem cells, Standard treatment of type Allergic Rhinitis according to the clinical protocols and Standard treatment of type Chronic Polypous Rhinosinusitis according to the clinical protocols in people with Allergic Rhinitis and Rhinosinusitis Chronic, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Natalia Antonevich, Dr (+375173691763, antonevich.n@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The relapse-free period (time frame: 6 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05167552.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.

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