An Early Phase 1 interventional study of nebulized human umbilical cord mesenchymal stromal cell-derived extracellular vesicles in IgG4 Related Disease and Systemic Sclerosis (SSc), sponsored by Qiubai Li. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Qiubai Li · Early Phase 1, Interventional, and Treatment
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.
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:
72 studies on the registry are indexed under Immunoglobulin G4-Related Disease; 40 are open to participants now.
This study's planned enrollment of 18 is below the median of 48 across 52 interventional studies indexed under Immunoglobulin G4-Related Disease.
Browse Immunoglobulin G4-Related Disease studies →Qiubai Li is the lead sponsor of 2 studies on the registry; 2 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.
For participants with IgG4-related disease:
For participants with systemic sclerosis:
Exclusion Criteria:
Inadequate organ function reserve, including any of the following:
Positive screening test results for , , , or syphilis, as defined below:
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.
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.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Biological: nebulized human umbilical cord mesenchymal stromal cell-derived extracellular vesicles
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.
Also known as: UC-EVs
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.
Time frame: 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.
Time frame: Through the first 14-day treatment cycle for each dose cohort
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline through Week 52
Change From Baseline in Bronchoalveolar Lavage Fluid Cellular and Cytokine Profiles
In participants who voluntarily undergo bronchoscopy and bronchoalveolar lavage fluid (BALF) collection, changes from baseline in BALF cellular characteristics and key inflammatory or immune-related cytokine levels will be assessed to explore local lung inflammation and immune microenvironment changes after UC-EV treatment.
Time frame: Baseline and Week 12
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jul 2028, 21 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Immunoglobulin G4-Related Disease →
Qiubai Li