IgG4 Related DiseaseEarly Phase 1NCT07806045
Nebulized UC-EVs for Recurrent or Refractory IMIDs With Lung Involvement
A Early Phase 1 study testing nebulized human umbilical cord mesenchymal stromal cell-derived extracellular vesicles in people with IgG4 Related Disease and Systemic Sclerosis (SSc), run by Qiubai Li at 1 site in China.
Trial summary
Immune-mediated inflammatory diseases (IMIDs) are systemic inflammatory disorders driven by dysregulated immune responses that can affect multiple organs, including the lungs. Examples include Behçet disease, IgG4-related disease, and systemic sclerosis (SSc). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- IgG4 Related Disease, Systemic Sclerosis (SSc)
- What is being tested?
- nebulized human umbilical cord mesenchymal stromal cell-derived extracellular vesicles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2026to 30 Jul 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years, inclusive, regardless of sex.
- Good compliance and willingness to receive study treatment and complete follow-up visits and assessments as required by the protocol.
- For participants with IgG4-related disease:
- Diagnosis of IgG4-related disease for at least 6 months, according to the 2019 ACR/EULAR Classification Criteria or the 2020 Revised Comprehensive Diagnostic Criteria for IgG4-related Disease.
- Evidence of IgG4-related lung involvement, including but not limited to bronchial wall thickening, bronchovascular bundle thickening, pulmonary nodules, or interstitial lung disease on chest high-resolution computed tomography (HRCT).
- For participants with systemic sclerosis:
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- Diagnosis of systemic sclerosis for at least 6 months, according to the 2013 ACR/EULAR Classification Criteria.
- Evidence of lung involvement on chest HRCT, including bronchial involvement, pulmonary nodules considered related to the underlying disease, and/or interstitial lung disease, with or without impaired pulmonary function.
- Able to understand the study purpose, procedures, and possible discomforts, and willing to provide written informed consent.
- Female participants of childbearing potential and male participants, including their female partners, must use highly effective contraception from screening until at least 6 months after the last dose. Participants must have no plan for pregnancy, sperm donation, or egg donation from screening until at least 6 months after the last dose.
Who cannot join
- Diagnosis before screening of any connective tissue disease other than IgG4-related disease or systemic sclerosis, or diagnosis of another interstitial lung disease, such as idiopathic pulmonary fibrosis or interstitial pneumonia with autoimmune features.
- Inadequate organ function reserve, including any of the following:
- Respiratory system: pulmonary arterial hypertension with pulmonary artery systolic pressure greater than 55 mmHg by echocardiography or mean pulmonary arterial pressure greater than 40 mmHg by right heart catheterization; severe impairment of diffusing capacity of the lung for carbon monoxide, defined as DLCO less than 30% of predicted; respiratory failure, defined as arterial oxygen tension less than 8 kPa or less than 60 mmHg and/or arterial carbon dioxide tension greater than 6.7 kPa or greater than 50 mmHg at rest without oxygen supplementation.
- Renal function: creatinine clearance less than 30 mL/min/1.73 m².
- Cardiac function: clinical symptoms of refractory congestive heart failure; left ventricular ejection fraction less than 35% by myocardial scintigraphy or echocardiography; chronic atrial fibrillation requiring oral anticoagulation; uncontrolled ventricular arrhythmia; or pericardial effusion causing hemodynamic instability by echocardiography.
- Liver function: persistent alanine aminotransferase, aspartate aminotransferase, or bilirubin greater than 3 times the upper limit of normal, or severe hepatic impairment, Child-Pugh class C.
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- Allergic constitution or history of potentially life-threatening drug allergy.
- Clinically significant chronic or recurrent infection, defined as 3 or more infections of the same type within 1 year, or recent severe infection, such as pneumonia or sepsis. Participants will also be excluded if, within 1 month before baseline, they required inhaled, intramuscular, or systemic antibiotic treatment, systemic antiviral treatment, hospitalization, or prolonged hospitalization for infection.
- History of organ transplantation or currently awaiting organ transplantation.
- Positive screening test results for hepatitis B, hepatitis C, human immunodeficiency virus, or syphilis, as defined below:
- Hepatitis B surface antigen positive.
- Hepatitis B surface antigen negative but hepatitis B core antibody positive, with hepatitis B virus DNA above the upper limit of normal.
- Hepatitis C virus antibody positive, with hepatitis C virus RNA above the upper limit of normal.
- Human immunodeficiency virus antibody positive.
- Treponema pallidum antibody positive with positive rapid plasma reagin or toluidine red unheated serum test.
- Possible active tuberculosis infection based on interferon-gamma release assay, such as QuantiFERON-TB Gold or T-SPOT.TB, clinical symptoms, and/or chest imaging. Participants with evidence of previously active tuberculosis that has been adequately treated may be enrolled after investigator assessment. Participants with latent tuberculosis may continue screening or be enrolled after at least 4 weeks of anti-tuberculosis treatment, if there is no liver injury before baseline and the investigator determines that the risk is controlled.
- Prior treatment with stem cells or extracellular vesicles.
- Any documented active or suspected malignancy, or history of malignancy, within 5 years before screening, except adequately treated basal cell carcinoma of the skin, squamous cell carcinoma in situ of the skin, or carcinoma in situ of the cervix.
- Self-harm or suicidal ideation within 1 year before screening.
- History of alcohol or drug abuse within 6 months before screening.
- Major surgery or clinically significant surgery within 6 months before screening, or planned major surgery during the study.
- Any of the following cardiovascular or cerebrovascular events within 6 months before screening: unstable angina requiring hospitalization, myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention, moderate to severe congestive heart failure defined as New York Heart Association class III or IV, atrial or ventricular arrhythmia requiring hospitalization, pacemaker or defibrillator implantation, cerebrovascular accident such as stroke, or planned coronary artery bypass grafting or revascularization during the study.
- History of psychiatric illness, epilepsy, or other central nervous system disease.
- Severe systemic disease, including but not limited to myocardial infarction, unstable angina, heart failure, liver cirrhosis, or acute glomerulonephritis.
- Participation in any other clinical trial within 3 months before screening or within 5 half-lives of the investigational product, whichever is longer.
- Pregnancy or breastfeeding.
- Poor compliance or inability to complete study procedures.
- Any condition that, in the investigator's opinion, may increase participant risk or interfere with interpretation of study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital
Beijing
Wen Zhang, MD, +86 13661131264, zhangwen91@sina.com
About this study
Official title: A Phase I, Multicenter, Single-Arm, Dose-Escalation Study of Nebulized Human Umbilical Cord Mesenchymal Stromal Cell-Derived Extracellular Vesicles in Patients With Recurrent or Refractory Immune-Mediated Inflammatory Diseases With Lung Involvement
Immune-mediated inflammatory diseases (IMIDs) are systemic inflammatory disorders driven by dysregulated immune responses that can affect multiple organs, including the lungs. Examples include Behçet disease, IgG4-related disease, and systemic sclerosis (SSc). IMID-related lung involvement may cause progressive lung damage, impaired lung function, disability, and increased mortality, but effective targeted treatment options remain limited.
This clinical trial will study nebulized human umbilical cord mesenchymal stromal cell-derived extracellular vesicles, also called UC-EVs, in adults with recurrent or refractory IMIDs with lung involvement.
Read the detailed description
This trial is an investigator initiated, multicenter, open-label, single-arm, dose-escalation trial. The main goal is to learn whether nebulized UC-EVs are safe and tolerable in adults with recurrent or refractory IMIDs with lung involvement.]. Researchers will also look for early signs of whether UC-EVs may help improve lung function, lung imaging findings, symptoms, and disease-related laboratory tests.
The study will include patients aged 18 and 80 years with IMID-related lung involvement. Eligible participants will have a diagnosis of IgG4-RD or SSc for at least 6 months. They must be receiving stable standard-of-care (SOC) treatment for the required period, as described in the inclusion criteria. They must also have adequate organ function and no history of severe allergy, as described in the eligibility criteria.
Eligible participants will:
- Inhale nebulized UC-EVs once daily for 7 days, followed by 7 days without treatment
- Repeat this 2-week treatment cycle 6 times, for a total treatment period of about 12 weeks
- Have study visits during treatment and follow-up visits through week 52
- Have safety checks, lung function tests, chest HRCT scans, blood tests, and symptom assessments
- Record symptoms, adverse events, and any rescue treatment in a study diary
- Conditions
- IgG4 Related Disease, Systemic Sclerosis (SSc)
- Being tested
- nebulized human umbilical cord mesenchymal stromal cell-derived extracellular vesicles
- Keywords
- IgG4 Related Disease, Systemic Sclerosis (SSc), Extracellular Vescicles, Umbilial Cord Mesenchymal Stromal Cell
- Medical subject headings
- Immunoglobulin G4-Related Disease, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nebulized human umbilical cord mesenchymal stromal cell-derived extracellular vesiclesBiological
Also called UC-EVs
UC-EVs are extracellular vesicles derived from human umbilical cord mesenchymal stromal cells. Participants will receive UC-EVs by nebulized inhalation once daily for 7 consecutive days, followed by 7 days without treatment. Each 14-day cycle will be repeated for 6 cycles over approximately 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| UC-EVs arm | Experimental | This open-label, dose-escalation study with up to three dose levels of nebulized UC-EVs. The maximum tolerated dose (MTD) of nebulized UC-EVs will be determined using dose-escalation 3+3 design.
Dose Level 1: 5×10^9 particles
Dose Level 2: 1×10^10 particles
Dose Level 3: 2×10^10 particles Receives: Biological: nebulized human umbilical cord mesenchymal stromal cell-derived extracellular vesicles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events and Serious Adverse Events
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) will be assessed in participants who receive at least one dose of nebulized UC-EVs. AEs and SAEs will be collected throughout the study and graded according to the protocol-defined safety assessment criteria.
Measured: From first dose through Week 52
Maximum Tolerated Dose and Recommended Phase 2 Dose of Nebulized UC-EVs
The maximum tolerated dose (MTD), if determinable, and the recommended Phase 2 dose (RP2D) of nebulized UC-EVs will be determined based on dose-limiting toxicities (DLTs), overall safety and tolerability, and available clinical and laboratory safety data during the dose-escalation phase.
Measured: Through the first 14-day treatment cycle for each dose cohort
Secondary outcomes (14)
Change From Baseline in Health Assessment Questionnaire Score
Absolute change from baseline in Health Assessment Questionnaire (HAQ) score during the study. HAQ is a participant-reported outcome measure used to assess physical function and daily activity. The total score ranges from 0 to 3, with higher scores indicating worse physical function and greater difficulty in daily activities. A decrease from baseline indicates improvement.
Measured: Baseline through Week 52
Change From Baseline in Patient Global Impression of Severity Score
Absolute change from baseline in Patient Global Impression of Severity (PGI-S) score during the study. PGI-S is used to assess the participant's overall perception of disease severity. The score ranges from 0 to 7, with higher scores indicating more severe disease symptoms. A decrease from baseline indicates improvement.
Measured: Baseline through Week 52
Change From Baseline in St. George's Respiratory Questionnaire Score
Absolute change from baseline in St. George's Respiratory Questionnaire (SGRQ) score during the study. SGRQ is a participant-reported outcome measure used to assess respiratory symptoms, activity limitation, and disease impact. The total score ranges from 0 to 100, with higher scores indicating worse respiratory health status. A decrease from baseline indicates improvement.
Measured: Baseline through Week 52
Change From Baseline in Leicester Cough Questionnaire Score
Absolute change from baseline in Leicester Cough Questionnaire (LCQ) score during the study. LCQ is a participant-reported outcome measure used to assess cough-related quality of life. The total score ranges from 3 to 21, with higher scores indicating better cough-related quality of life. An increase from baseline indicates improvement.
Measured: Baseline through Week 52
Change From Baseline in Forced Vital Capacity at Week 24
Absolute change from baseline in forced vital capacity (FVC), measured in milliliters, at Week 24.
Measured: Baseline to Week 24
Percent Change From Baseline in Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide at Week 24
Percent change from baseline in percent predicted single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB % predicted) at Week 24.
Measured: Baseline to Week 24
Change From Baseline in Maximum Pulmonary Nodule Size on Chest HRCT at Week 24
For participants with pulmonary nodules at baseline, absolute change from baseline in the size of the largest pulmonary nodule on chest high-resolution computed tomography (HRCT), measured in millimeters, at Week 24.
Measured: Baseline to Week 24
Change From Baseline in Bronchial Wall Thickness on Chest HRCT at Week 24
For participants with bronchial wall thickening at baseline, absolute change from baseline in bronchial wall thickness on chest HRCT, measured in millimeters, at Week 24.
Measured: Baseline to Week 24
Change From Baseline in Quantitative Lung Fibrosis and Quantitative Ground-Glass Opacity Scores on Chest HRCT at Week 24
For participants with interstitial lung disease at baseline, absolute change from baseline in quantitative lung fibrosis (QLF) score and quantitative ground-glass opacity (QGGO) score on chest HRCT at Week 24. Scores are expressed as percentages.
Measured: Baseline to Week 24
Change From Baseline in Quantitative Interstitial Lung Disease Score on Chest HRCT at Week 24
For participants with interstitial lung disease at baseline, absolute change from baseline in quantitative interstitial lung disease (QILD) score on chest HRCT at Week 24. The score is expressed as a percentage.
Measured: Baseline to Week 24
Change From Baseline in Disease-Related Serologic Markers (for IgG4-RD patients only)
Absolute change from baseline in serum IgG4 level (mg/L) for participants with IgG4-related disease.
Measured: Baseline through Week 52
Change From Baseline in Disease-Related Serologic Markers (for SSc patients only)
Absolute change from baseline in systemic sclerosis-related autoantibody titers (U/mL) for participants with systemic sclerosis.
Measured: Baseline through Week 52
Change From Baseline in erythrocyte sedimentation rate
Absolute change from baseline in erythrocyte sedimentation rate (ESR) (mm/h) level during the study.
Measured: Baseline through Week 52
Change From Baseline in C-reactive protein
Absolute change from baseline in C-reactive protein (CRP) (mg/L) levels during the study.
Measured: Baseline through Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start14 Oct 2026 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgG4 Related DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qiubai Li
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Shandong Qilu Stem Cells Engineering Co., Ltd.
- Responsible party
- Sponsor-investigator, Qiubai Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Qiubai Li, MD, Principal investigator, Department of Rheumatology, Wuhan Union Hospital, Tongji Medical College of Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806045
- Sponsor's protocol ID
- UCEV-IMID 2.0
- Status last verified
- Jul 2026
- First submitted
- 29 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because this is an early-phase, small-sample study involving patients with rare immune-mediated inflammatory diseases and detailed clinical, imaging, laboratory, safety, and exploratory biomarker data. Even after de-identification, there may remain a risk of participant re-identification. De-identified aggregate data will be reported in publications and/or trial registry results as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Single-Arm, Dose-Escalation Study of Nebulized Human Umbilical Cord Mesenchymal Stromal Cell-Derived Extracellular Vesicles in Patients With Recurrent or Refractory Immune-Mediated Inflammatory Diseases With Lung Involvement
- ClinicalTrials.gov ID
- NCT07806045
- Acronym / sponsor ID
- UCEV-IMID 2.0
- Conditions
- IgG4 Related Disease, Systemic Sclerosis (SSc)
- Keywords
- IgG4 Related Disease, Systemic Sclerosis (SSc), Extracellular Vescicles, Umbilial Cord Mesenchymal Stromal Cell
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Qiubai LiUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Shandong Qilu Stem Cells Engineering Co., Ltd.
- Study start
- 14 Oct 2026 (estimated)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Immune-mediated inflammatory diseases (IMIDs) are systemic inflammatory disorders driven by dysregulated immune responses that can affect multiple organs, including the lungs. Examples include Behçet disease, IgG4-related disease, and systemic sclerosis (SSc). IMID-related lung involvement may cause progressive lung damage, impaired lung function, disability, and increased mortality, but effective targeted treatment options remain limited.
This clinical trial will study nebulized human umbilical cord mesenchymal stromal cell-derived extracellular vesicles, also called UC-EVs, in adults with recurrent or refractory IMIDs with lung involvement.
Detailed description
This trial is an investigator initiated, multicenter, open-label, single-arm, dose-escalation trial. The main goal is to learn whether nebulized UC-EVs are safe and tolerable in adults with recurrent or refractory IMIDs with lung involvement.]. Researchers will also look for early signs of whether UC-EVs may help improve lung function, lung imaging findings, symptoms, and disease-related laboratory tests.
The study will include patients aged 18 and 80 years with IMID-related lung involvement. Eligible participants will have a diagnosis of IgG4-RD or SSc for at least 6 months. They must be receiving stable standard-of-care (SOC) treatment for the required period, as described in the inclusion criteria. They must also have adequate organ function and no history of severe allergy, as described in the eligibility criteria.
Eligible participants will:
- Inhale nebulized UC-EVs once daily for 7 days, followed by 7 days without treatment
- Repeat this 2-week treatment cycle 6 times, for a total treatment period of about 12 weeks
- Have study visits during treatment and follow-up visits through week 52
- Have safety checks, lung function tests, chest HRCT scans, blood tests, and symptom assessments
- Record symptoms, adverse events, and any rescue treatment in a study diary
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UC-EVs arm | Experimental | Biological: nebulized human umbilical cord mesenchymal stromal cell-derived extracellular vesiclesThis open-label, dose-escalation study with up to three dose levels of nebulized UC-EVs. The maximum tolerated dose (MTD) of nebulized UC-EVs will be determined using dose-escalation 3+3 design. Dose Level 1: 5×10^9 particles Dose Level 2: 1×10^10 particles Dose Level 3: 2×10^10 particles |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 to 80 years, inclusive, regardless of sex.
- Good compliance and willingness to receive study treatment and complete follow-up visits and assessments as required by the protocol.
- For participants with IgG4-related disease:
- For participants with systemic sclerosis:
- Able to understand the study purpose, procedures, and possible discomforts, and willing to provide written informed consent.
Key exclusion criteria (28 listed)
- Diagnosis before screening of any connective tissue disease other than IgG4-related disease or systemic sclerosis, or diagnosis of another interstitial lung disease, such as idiopathic pulmonary fibrosis or interstitial pneumonia with autoimmune features.
- Inadequate organ function reserve, including any of the following:
- Allergic constitution or history of potentially life-threatening drug allergy.
- Clinically significant chronic or recurrent infection, defined as 3 or more infections of the same type within 1 year, or recent severe infection, such as pneumonia or sepsis. Participants will also be excluded if, within 1 month before baseline, they required inhaled, intramuscular, or systemic antibiotic treatment, systemic antiviral treatment, hospitalization, or prolonged hospitalization for infection.
- History of organ transplantation or currently awaiting organ transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nebulized human umbilical cord mesenchymal stromal cell-derived extracellular vesiclesAlso: UC-EVsUC-EVs are extracellular vesicles derived from human umbilical cord mesenchymal stromal cells. Participants will receive UC-EVs by nebulized inhalation once daily for 7 consecutive days, followed by 7 days without treatment. Each 14-day cycle will be repeated for 6 cycles over approximately 12 weeks. | Biological | UC-EVs arm |
Primary outcome
Incidence and Severity of Adverse Events and Serious Adverse Events
Time frame: From first dose through Week 52
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) will be assessed in participants who receive at least one dose of nebulized UC-EVs. AEs and SAEs will be collected throughout the study and graded according to the protocol-defined safety assessment criteria.
Maximum Tolerated Dose and Recommended Phase 2 Dose of Nebulized UC-EVs
Time frame: Through the first 14-day treatment cycle for each dose cohort
The maximum tolerated dose (MTD), if determinable, and the recommended Phase 2 dose (RP2D) of nebulized UC-EVs will be determined based on dose-limiting toxicities (DLTs), overall safety and tolerability, and available clinical and laboratory safety data during the dose-escalation phase.
14 secondary outcomes
Change From Baseline in Health Assessment Questionnaire Score
Time frame: Baseline through Week 52
Change From Baseline in Patient Global Impression of Severity Score
Time frame: Baseline through Week 52
Change From Baseline in St. George's Respiratory Questionnaire Score
Time frame: Baseline through Week 52
Change From Baseline in Leicester Cough Questionnaire Score
Time frame: Baseline through Week 52
Change From Baseline in Forced Vital Capacity at Week 24
Time frame: Baseline to Week 24
Percent Change From Baseline in Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide at Week 24
Time frame: Baseline to Week 24
Change From Baseline in Maximum Pulmonary Nodule Size on Chest HRCT at Week 24
Time frame: Baseline to Week 24
Change From Baseline in Bronchial Wall Thickness on Chest HRCT at Week 24
Time frame: Baseline to Week 24
Change From Baseline in Quantitative Lung Fibrosis and Quantitative Ground-Glass Opacity Scores on Chest HRCT at Week 24
Time frame: Baseline to Week 24
Change From Baseline in Quantitative Interstitial Lung Disease Score on Chest HRCT at Week 24
Time frame: Baseline to Week 24
Change From Baseline in Disease-Related Serologic Markers (for IgG4-RD patients only)
Time frame: Baseline through Week 52
Change From Baseline in Disease-Related Serologic Markers (for SSc patients only)
Time frame: Baseline through Week 52
Change From Baseline in erythrocyte sedimentation rate
Time frame: Baseline through Week 52
Change From Baseline in C-reactive protein
Time frame: Baseline through Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because this is an early-phase, small-sample study involving patients with rare immune-mediated inflammatory diseases and detailed clinical, imaging, laboratory, safety, and exploratory biomarker data. Even after de-identification, there may remain a risk of participant re-identification. De-identified aggregate data will be reported in publications and/or trial registry results as appropriate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qiubai Li, MD principal investigator
Department of Rheumatology, Wuhan Union Hospital, Tongji Medical College of Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing nebulized human umbilical cord mesenchymal stromal cell-derived extracellular vesicles in people with IgG4 Related Disease and Systemic Sclerosis (SSc), run by Qiubai Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiubai Li, MD (+86 13995671635, qiubaili@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Adverse Events and Serious Adverse Events (time frame: From first dose through Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.