Could inhaled stem cell particles ease allergies and asthma?
NCT ID NCT07453771
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial is testing whether inhaling tiny particles from stem cells (called small extracellular vesicles) can safely help people with both allergic rhinitis and asthma. About 18 adults will receive either the active treatment or a placebo via nebulizer daily for two weeks. Researchers will monitor symptoms, lung function, and side effects for up to 24 weeks to see if the approach is promising.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- stem cell-derived small extracellular vesicles (hUC-MSC-sEV-002)
- What this could lead to
- If it works, this could point toward a new way to control allergic rhinitis and asthma symptoms with a simple inhaled treatment.
- What could go wrong
- This is a very early, small trial (only 18 people) testing safety and dosing. It may not show clear benefit, and the treatment could cause side effects or fail to work in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Mar 2026
An estimate. Start dates often move.
- Expected to finish
-
Aug 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18-60 years, regardless of gender; 2. Patients with moderate to severe allergic rhinitis (with sleep/work/study/daily activity impairment or distressing symptoms) meeting the diagnostic criteria of the international Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines, positive for at least one inhalant allergen skin prick test, and concurrent asthma complying with the Global Initiative for Asthma (GINA) 2022 guidelines; 3. Suboptimal response to antiallergic medication treatment for one year prior to enrollment; 4. Patients who decline allergen-specific immunotherapy, or have no available specific therapy for the relevant allergen, or failed allergen-specific immunotherapy; 5. Females of childbearing potential must agree to avoid pregnancy during study participation and for 30 days after the final visit; 6. Subjects or their legal representatives must be able to sign the informed consent form and comply with the study requirements for medication administration and follow-up. Exclusion Criteria: 1. Complicated with other nasal and sinus diseases that may affect the reasonable assessment of efficacy and/or safety; 2. Suffering from uncontrolled asthma or poorly controlled asthma symptoms; 3. Suffering from malignant tumors, severe immune diseases, long-term use of immunosuppressants, or immunodeficiency; 4. Having unstable conditions due to respiratory tract infection and/or acute asthma exacerbation within 4 weeks prior to the initial screening visit; 5. Currently receiving treatment with beta-blockers or angiotensin-converting enzyme (ACE) inhibitors; 6. Suffering from mental illnesses; 7. Suffering from severe systemic diseases, such as cases of peptic ulcers, diabetes mellitus, and heart failure; 8. Specific infections such as syphilis, leprosy, and tuberculosis; 9. Females who are currently pregnant, planning to become pregnant soon, or breastfeeding; 10. Patients who are currently participating in other clinical trials or have participated in other clinical trials within 30 days prior to the initial screening visit; 11. Patients who are currently receiving allergen desensitization therapy or biologic therapy; 12. Positive for hepatitis B surface antigen, hepatitis C virus antibody, syphilis serological antibody, or human immunodeficiency virus (HIV) antibody; 13. In addition to the above conditions, patients will be excluded if the investigators consider them unsuitable for participation in this clinical study for other reasons.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Allergic rhinitis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
5 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Chongqing General Hospital
Chongqing, 401121, China
-
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266100, China
-
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
-
The Second Affiliated Hospital of Shandong First Medical University
Tai’an, Shandong, 271000, China
-
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a simple breath test cut asthma Flare-Ups?
- Breathing tests face off: can extra lung measurements improve asthma diagnosis?
- The carbon label on your inhaler: can it sway a Doctor's choice?
- Six biologics put to the test in Real-World asthma and COPD care
- Can a digital program help teens with chronic illnesses move to adult care?
- Why do some kids catch every cold? a 1,200-Child study hunts for immune clues