This trial aims to evaluate the safety, tolerability and efficacy of hUC-MSC-sEV-002 nebulizer in patients with allergic rhinitis and asthma. It consists of two parts: ① Single-center dose exploration (The Affiliated Hospital of Qingdao University): A 3+3 escalation design will test three doses (1×10⁸, 1×10⁹, 1×10¹⁰ particles/mL) to determine the maximum tolerated dose (MTD).Three subjects will be enrolled in each dose group. If no Dose-Limiting Toxicity (DLT) is observed among the 3 subjects, the study may proceed to the next dose exploration. If 1 out of the 3 subjects experiences DLT, an additional 3 subjects will be enrolled in the same dose group; the study may move to the next dose exploration only if no DLT is observed in these additional 3 subjects. If more than 1 out of the 3 subjects develops DLT, the previous dose group will be defined as the MTD. A total of at least 9 and at most 18 subjects will be recruited for this clinical trial. ② Multi-center case expansion: Participants will be randomized 2:1 to hUC-MSC-sEV-002 or placebo groups for efficacy comparison.Eligibility criteria: 18-60 years old; moderate-to-severe allergic rhinitis (ARIA guidelines) with positive inhaled allergen skin test; asthma diagnosed per GINA 2022; signed informed consent.Intervention: Nebulization once daily (5 times/week, 2 weeks, 10 doses total). Follow-up visits at baseline, Week 2, 4, 12, 24, including symptom scales, lung function tests, nasal endoscopy, nasal exhaled nitric oxide test, chest X-ray, blood tests, and electrocardiogram. The trial is approved by the Medical Ethics Committee of The Affiliated Hospital of Qingdao University (No. QYFYEC2025-192). Participants may withdraw anytime without affecting medical care. Study period: Aug 2025-Aug 2027. Sample size: 9-18 for Part 1; Part 2 size based on Part 1 results.
Age range
18 Years – 60 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Timeframe: At Week 24
Forced Expiratory Volume in One Second (FEV1)
Timeframe: At Week 24
Drug-related adverse reaction rate
Timeframe: In the short term after treatment (0-24 hours)；At Week 2
Blood Pressure
Timeframe: At Week 2
Changes in routine blood test
Timeframe: At Week 2
Changes in routine urine test
Timeframe: At Week 2
Whether abnormal changes occurred in the ECG
Timeframe: At Week 2
Total Nasal Symptom Score (TNSS)
Timeframe: At Week 24
Visual Analog Scale (VAS)
Timeframe: At Week 24
Asthma Control Test (ACT)
Timeframe: At Week 24
Peak Expiratory Flow (PEF)
Timeframe: At Week 24
Heart Rate
Timeframe: At Week 2
Body Temperature
Timeframe: At Week 2
C-reactive protein (CRP)
Timeframe: At Week 2
Alanine aminotransferase (ALT)
Timeframe: At Week 2
Creatinine
Timeframe: At Week 2
IgG, IgA, IgM, C3 ,C4
Timeframe: At Week 2
Aspartate aminotransferase (AST)
Timeframe: At Week 2