An interventional study of hUC-MSC-sEV-002 Nebulizer and hUC-MSC-sEV-002 Mimetic (Normal Saline) in Allergic Rhinitis and Asthma, sponsored by The Affiliated Hospital of Qingdao University. Not yet recruiting at 5 sites in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by The Affiliated Hospital of Qingdao University · Not applicable, Interventional, and Treatment
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.
Allergic rhinitis is an independent risk factor for asthma. As inflammatory disorders affecting the upper and lower airways respectively, allergic rhinitis and asthma share similar pathogenesis and interact with each other, thus being recognized as "one airway, one disease". Their incidence rates are increasing year by year with a wide distribution, and they often coexist. These conditions have become an important issue affecting people's quality of life worldwide and imposed a heavy economic burden on society. In the treatment of allergic rhinitis complicated with asthma, glucocorticoids, antihistamines, leukotriene receptor antagonists and other agents are the most commonly used drugs. However, long-term use of these drugs is prone to induce various adverse reactions. Moreover, drug resistance and intolerance observed in some patients have also limited the widespread application of these medications. Therefore, there is an urgent need for novel therapeutic approaches for allergic diseases.
Small extracellular vesicles derived from mesenchymal stem cells not only possess immunomodulatory functions similar to those of mesenchymal stem cells, but also exhibit more advantages in clinical applications, including no tumorigenic risk, small size, stable performance, easy transportation and preservation, low immunogenicity, and the ability to penetrate biological barriers. Therefore, they hold great potential and broad application prospects in the treatment of allergic rhinitis complicated with asthma.
This is a multicenter, prospective, randomized, double-blind, placebo-controlled, dose-finding clinical trial, designed to evaluate the safety and preliminary efficacy of nebulized human umbilical cord blood mesenchymal stem cell-derived small extracellular vesicles (code: hUC-MSC-sEV-002) in the treatment of allergic rhinitis complicated with asthma. The trial consists of two phases, namely the dose-finding phase (Phase I clinical trial) and the cohort expansion phase (Phase II clinical trial). It encompasses three study periods: the screening period (Visit 0, Weeks -2 to 0), the treatment period (Visit 1, Week 2), and the follow-up period (Visit 2, Week 4; Visit 3, Week 12; Visit 4, Week 24). The scheduled visit plan includes baseline assessment, the end of Week 2, the end of Week 4, Week 12, and Week 24.
Primary safety endpoints include dose-limiting toxicities (DLT) associated with nebulized hUC-MSC-sEV-002, covering the following aspects: the incidence of drug-related adverse reactions occurring within the short-term post-treatment period (0 to 24 hours); the incidence of drug-related adverse reactions within 2 weeks of treatment; changes in vital signs, complete blood count plus C-reactive protein (CRP), urine routine, liver and kidney function, immune profile panel (IgG, IgA, IgM, C3, C4), and electrocardiogram (ECG) from baseline to the end of Week 2 of treatment.
Secondary safety endpoints include the incidence of adverse events at Week 12 and Week 24 of treatment; changes in vital signs, complete blood count, urine routine, liver and kidney function, immune profile panel, and electrocardiogram (ECG) from baseline to Week 12 and Week 24 of treatment; pulmonary function tests at Week 2 and Week 24 of treatment; and chest X-ray examination at Week 24 of treatment.
Questionnaire (RQLQ) scores, Total Nasal Symptom Score (TNSS), Visual Analog Scale (VAS) scores, Asthma Control Test (ACT) scores, forced expiratory volume in one second (FEV₁), and peak expiratory flow (PEF) at Week 24 of treatment.
Secondary efficacy endpoints include the percentage changes from baseline in the Rhinitis Quality of Life Questionnaire (RQLQ) scores, Total Nasal Symptom Score (TNSS), and Visual Analog Scale (VAS) scores at the end of Week 2, end of Week 4, and Week 12 of treatment; the percentage changes from baseline in forced expiratory volume in one second (FEV₁), peak expiratory flow (PEF), and Asthma Control Test (ACT) scores at the end of Week 2, end of Week 4, and Week 12 of treatment; the percentage changes from baseline in total serum IgE, specific IgE, and IgG4 levels at Week 12 and Week 24 of treatment; and the changes in nasal endoscopy findings and nasal exhaled nitric oxide test results from baseline to Week 12 and Week 24 of treatment.
Exploratory endpoints include the changes from baseline in plasma cytokines (IFN-γ, IL-6, IL-4, IL-5, IL-13), peripheral blood lymphocytes, and the subsets of Th1, Th2, Th17 and ILC2 at the end of Week 2, Week 12 and Week 24 of treatment; as well as the changes from baseline in nasal secretion cytokines (ECP, IL-6, IFN-γ, IL-5, IL-13, IL-33) at the end of Week 2, Week 12 and Week 24 of treatment.
All adverse events occurring in all subjects during the clinical study shall be monitored closely. The adverse event forms shall be completed in a timely manner, with detailed documentation of clinical manifestations, severity, time of onset, duration, measures taken and clinical outcomes. The study shall not be initiated until the clinical study protocol and the informed consent form have been submitted to and approved by the Institutional Review Board (IRB).
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
This study's planned enrollment of 18 is below the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.
Browse Rhinitis, Allergic studies →The Affiliated Hospital of Qingdao University is the lead sponsor of 149 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
hUC-MSC-sEV-002 nebulizer, nebulization therapy, once daily, 5 nebulizations per week, for 2 consecutive weeks, totaling 10 times.
Other: hUC-MSC-sEV-002 Nebulizer
A control arm is established in Phase II of the clinical trial.hUC-MSC-sEV-002 Mimetic (Normal Saline), nebulization therapy, once daily, 5 nebulizations per week, for 2 consecutive weeks, totaling 10 times.
Other: hUC-MSC-sEV-002 Mimetic (Normal Saline)
Nebulization therapy, once daily, 5 nebulizations per week, for 2 consecutive weeks, totaling 10 times.
Nebulization 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.
Time frame: At Week 24
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.
Time frame: At Week 24
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.
Time frame: In the short term after treatment (0-24 hours)；At Week 2
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.
Time frame: At Week 2
Changes in routine blood test
We performed routine blood tests via venous blood collection and recorded any changes compared with baseline.
Time frame: At Week 2
Changes in routine urine test
Urine specimens were collected for routine urinalysis, and any abnormal changes from baseline were documented.
Time frame: At Week 2
Whether abnormal changes occurred in the ECG
Electrocardiography (ECG) will be performed to evaluate whether there are any abnormalities in the patient's heart rate or cardiac rhythm.
Time frame: At Week 2
Total Nasal Symptom Score (TNSS)
It consists of 4 items, with each item scored on a scale of 0 to 3. The total score ranges from 0 to 12, with a higher total score indicating more severe disease symptoms.
Time frame: At Week 24
Visual Analog Scale (VAS)
It is used to assess the severity of symptoms, with the total score ranging from 0 to 10. A higher total score indicates more severe disease symptoms.
Time frame: At Week 24
Asthma Control Test (ACT)
It is used to assess asthma control, with the total score ranging from 0 to 25. A higher total score indicates better asthma control.
Time frame: At Week 24
Peak Expiratory Flow (PEF)
Pulmonary function tests are conducted to obtain the value of PEF, with the unit of PEF being liters per second (L/s). A percentage of the measured PEF value relative to the predicted value of 80% or higher is defined as normal.
Time frame: At Week 24
Heart Rate
The unit of heart rate is beats per minute, with a normal range of 60 to 100 bpm.
Time frame: At Week 2
Body Temperature
The unit is degrees Celsius (°C), with a normal range of 36.0 °C to 37.0 °C.
Time frame: At Week 2
C-reactive protein (CRP)
Venous blood sampling is performed for C-reactive protein (CRP) testing.The unit is mg/L, with a normal reference range of 0 to 5 mg/L.
Time frame: At Week 2
Alanine aminotransferase (ALT)
Venous blood sampling is performed for liver function tests. Alanine aminotransferase (ALT) is measured in U/L, with a normal reference range of 7-40 U/L for females and 9-50 U/L for males.
Time frame: At Week 2
Creatinine
Venous blood sampling is performed for renal function tests.The unit for creatinine is μmol/L, with a normal reference range of 41-81 μmol/L for females and 57-111 μmol/L for males.
Time frame: At Week 2
IgG, IgA, IgM, C3 ,C4
Venous blood sampling is performed for five immunological indicators, which mainly includes IgG, IgA, IgM, C3 and C4.The units for all the above indicators are g/L. Normal reference ranges:IgG: 8.6-17.4 g/L；IgA: 1.0-4.2 g/L；IgM: 0.3-2.2 g/L；C3: 0.7-1.4 g/L；C4: 0.1-0.4 g/L.
Time frame: At Week 2
Aspartate aminotransferase (AST)
Venous blood sampling is performed for liver function tests. Aspartate aminotransferase (AST) is measured in U/L, with a normal reference range of 13-35 U/L for females and 15-40 U/L for males.
Time frame: At Week 2
Adverse event rate
The incidence of adverse events at 12 and 24 weeks post-treatment.
Time frame: At Week 12; At Week 24
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.
Time frame: At Week 12; At Week 24
Changes in routine blood test
We performed routine blood tests via venous blood collection and recorded any changes compared with baseline.
Time frame: At Week 12; At Week 24
Changes in routine urine test
Urine specimens were collected for routine urinalysis, and any abnormal changes from baseline were documented.
Time frame: At Week 12; At Week 24
Whether abnormal changes occurred in the ECG
Electrocardiography (ECG) will be performed to evaluate whether there are any abnormalities in the patient's heart rate or cardiac rhythm.
Time frame: At Week 12; At Week 24
Chest X-ray
A chest X-ray shall be performed at Week 24 of treatment to evaluate for any abnormal pulmonary imaging findings.
Time frame: At Week 24
Rhinitis-Conjunctivitis 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.
Time frame: At Week 2; At Week 4; At Week 12
Forced Expiratory Volume in 1 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.
Time frame: At Week 2; At Week 4; At Week 12; At Week 24
Total Serum Immunoglobulin E (IgE)
Venous blood samples are collected for total serum IgE testing, with the unit of IU/mL. The normal range is 0 to 100 IU/mL.
Time frame: At Week 12; At Week 24
Nasal endoscopy
Nasal endoscopy shall be performed to assess for any structural abnormalities or abnormal hyperplastic lesions in the nasal cavity, and to evaluate for any abnormal changes in the nasal mucosa.
Time frame: After 12 weeks of treatment；After 24 weeks of treatment
Nasal Exhaled Nitric Oxide
The concentration of nitric oxide in nasal exhalation is measured using a nasal exhaled nitric oxide analyzer.
Time frame: At Week 12; At Week 24
Heart Rate
The unit of heart rate is beats per minute, with a normal range of 60 to 100 bpm.
Time frame: At Week 12; At Week 24
Body Temperature
The unit is degrees Celsius (°C), with a normal range of 36.0 °C to 37.0 °C.
Time frame: At Week 12; At Week 24
C-reactive protein (CRP)
Venous blood sampling is performed for C-reactive protein (CRP) testing.The unit is mg/L, with a normal reference range of 0 to 5 mg/L.
Time frame: At Week 12; At Week 24
Alanine aminotransferase (ALT)
Venous blood sampling is performed for liver function tests. Alanine aminotransferase (ALT) is measured in U/L, with a normal reference range of 7-40 U/L for females and 9-50 U/L for males.
Time frame: At Week 12; At Week 24
Creatinine
Venous blood sampling is performed for renal function tests.The unit for creatinine is μmol/L, with a normal reference range of 41-81 μmol/L for females and 57-111 μmol/L for males.
Time frame: At Week 12; At Week 24
IgG, IgA, IgM, C3,C4
Venous blood sampling is performed for five immunological indicators, which mainly includes IgG, IgA, IgM, C3 and C4.The units for all the above indicators are g/L. Normal reference ranges:IgG: 8.6-17.4 g/L；IgA: 1.0-4.2 g/L；IgM: 0.3-2.2 g/L；C3: 0.7-1.4 g/L；C4: 0.1-0.4 g/L.
Time frame: At Week 12; At Week 24
Peak Expiratory Flow (PEF)
Pulmonary function tests are conducted to obtain the value of PEF, with the unit of PEF being liters per second (L/s). A percentage of the measured PEF value relative to the predicted value of 80% or higher is defined as normal.
Time frame: At Week 2; At Week 4;At Week 12; At Week 24
Total Nasal Symptom Score (TNSS)
It consists of 4 items, with each item scored on a scale of 0 to 3. The total score ranges from 0 to 12, with a higher total score indicating more severe disease symptoms.
Time frame: At Week 2; At Week 4; At Week 12
Visual Analog Scale (VAS)
It is used to assess the severity of symptoms, with the total score ranging from 0 to 10. A higher total score indicates more severe disease symptoms.
Time frame: At Week 2; At Week 4; At Week 12
Asthma Control Test (ACT)
It is used to assess asthma control, with the total score ranging from 0 to 25. A higher total score indicates better asthma control.
Time frame: At Week 2; At Week 4; At Week 12
Specific Immunoglobulin E (sIgE)
Venous blood samples are collected for specific IgE (sIgE) testing, with the unit of kU/L. The normal value is less than 60 kU/L.
Time frame: At Week 12; At Week 24
Immunoglobulin G4 (IgG4)
Venous blood samples are collected for IgG4 testing, with the unit of g/L. The normal range is 0.03 to 2.01 g/L.
Time frame: At Week 12; At Week 24
Aspartate aminotransferase (AST)
Venous blood sampling is performed for liver function tests. Aspartate aminotransferase (AST) is measured in U/L, with a normal reference range of 13-35 U/L for females and 15-40 U/L for males.
Time frame: At Week 12; At Week 24
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.
Time frame: At Week 2; At Week 12; At Week 24
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.
Time frame: At Week 2; At Week 12; At Week 24
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.
Time frame: At Week 2; At Week 12; At Week 24
Plan to share: No — The informed consent form of this study does not include clauses authorizing IPD sharing. As a Phase I/II exploratory study, the data involves sensitive medical information and preliminary research results. To protect participants' privacy and comply with ethical and regulatory requirements, the data will not be shared.
No publications or documents are linked to this record.
Start is estimated for Mar 2026; primary completion for Feb 2027, 11 months later.
Of 66 non-industry interventional studies with no phase under Rhinitis, Allergic, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 28. This study's planned 11 months is below that.
Counting every sponsor, half of 87 studies reached it within 11 months; a quarter within 4 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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The Affiliated Hospital of Qingdao University →