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.
Aged 18-60 years, regardless of gender;
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;
Suboptimal response to antiallergic medication treatment for one year prior to enrollment;
Patients who decline allergen-specific immunotherapy, or have no available specific therapy for the relevant allergen, or failed allergen-specific immunotherapy;
Complicated with other nasal and sinus diseases that may affect the reasonable assessment of efficacy and/or safety;
Suffering from uncontrolled asthma or poorly controlled asthma symptoms;
Suffering from malignant tumors, severe immune diseases, long-term use of immunosuppressants, or immunodeficiency;
Having unstable conditions due to respiratory tract infection and/or acute asthma exacerbation within 4 weeks prior to the initial screening visit;
Parallel
hUC-MSC-sEV-002 Nebulizer
Other interventionNebulization therapy, once daily, 5 nebulizations per week, for 2 consecutive weeks, totaling 10 times.
hUC-MSC-sEV-002 Mimetic (Normal Saline)
Other interventionNebulization therapy, once daily, 5 nebulizations per week, for 2 consecutive weeks, totaling 10 times.
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
It consists of 7 domains and 28 items, with each item scored on a scale of 0 to 6. Each domain is scored independently, and the sum of all domain scores yields the total RQLQ score, which ranges from 0 to 168. A higher total score indicates a greater negative impact of the disease on the patient's quality of life.
Forced Expiratory Volume in One Second (FEV1)
Pulmonary function tests are conducted to obtain the value of FEV1, with the unit of FEV1 being liters (L). A percentage of the measured FEV1 value relative to the predicted value of 80% or higher is defined as normal.
Drug-related adverse reaction rate
The incidence of treatment-related adverse events within the short-term post-treatment period (0 to 24 hours);The incidence of treatment-related adverse events at 2 weeks post-treatment.
Blood Pressure
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) shall be measured separately. The reference range for SBP is 90 mmHg to 139 mmHg, and the reference range for DBP is 60 mmHg to 89 mmHg.
Adverse event rate
The incidence of adverse events at 12 and 24 weeks post-treatment.
Blood Pressure
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) shall be measured separately. The reference range for SBP is 90 mmHg to 139 mmHg, and the reference range for DBP is 60 mmHg to 89 mmHg.
Changes in routine blood test
We performed routine blood tests via venous blood collection and recorded any changes compared with baseline.
Changes in routine urine test
Urine specimens were collected for routine urinalysis, and any abnormal changes from baseline were documented.
Plasma Cytokines
Venous blood samples are collected for the measurement of plasma cytokines, including IFN-γ, IL-6, IL-4, IL-5 and IL-13. The units for these indicators are all pg/ml.This indicator is an exploratory measure, and no normal reference range is available.
Nasal secretion cytokines
Nasal secretion cytokines include ECP, IL-6, IFN-γ, IL-5, IL-13, and IL-33.The units for these indicators are all pg/ml. These are exploratory measures, and no normal reference range is available.
Peripheral Blood Lymphocyte Subsets
Peripheral blood lymphocyte subset analysis includes Th1, Th2, Th17, and ILC2. This is an exploratory endpoint, and no normal reference range is available.
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