Stem cell nasal spray takes on sinusitis
NCT ID NCT07635459
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new nasal spray for adults with chronic sinusitis. The spray turns into a gel inside the nose and releases three active ingredients: stem cell exosomes to help repair the nasal lining, an antihistamine to reduce inflammation, and an antiviral agent. The goal is to see if it is safe and can ease symptoms during a flare-up. 108 participants will be randomly assigned to receive the full spray, a version without exosomes, or a placebo gel.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a gel nasal spray containing stem cell exosomes, azelastine (antihistamine), and interferon alpha-2b (antiviral)
- What this could lead to
- If it works, this spray could offer a new way to manage chronic sinusitis flare-ups by reducing inflammation and fighting viruses.
- What could go wrong
- This is a very early (Phase 1) study focused on safety, not effectiveness. The spray is complex and may cause side effects like irritation or taste changes. Success is far from guaranteed.
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
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 108 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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: * Age 18 to 65 years, both genders * Diagnosis of chronic rhinosinusitis according to Chinese guidelines (2018) or EPOS 2020, duration \>12 weeks * Lund-Kennedy endoscopic score ≥4 * SNOT-22 score ≥30 * Nasal symptoms stable in past month, or acute flare-ups not requiring systemic antibiotics/steroids * Voluntary signed informed consent Exclusion Criteria: * Sinus surgery within past 6 months or anatomical abnormalities requiring reoperation * Allergic fungal rhinosinusitis, odontogenic rhinosinusitis, or nasal polyps * Primary ciliary dyskinesia, cystic fibrosis, or severe immunodeficiency * Use of systemic glucocorticoids, immunosuppressants, or antibiotics within past 4 weeks * Use of intranasal glucocorticoids, antihistamines, or leukotriene receptor antagonists within past 2 weeks * Hypersensitivity to poloxamer, chitosan, azelastine, or interferon * Pregnant, breastfeeding, or planning to become pregnant * Uncontrolled severe systemic diseases (diabetes, hypertension, autoimmune diseases) * Malignancy within past 5 years * Participation in other clinical trials
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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.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.