Could stem cells offer new hope for autoimmune lung damage?
NCT ID NCT06574581
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a stem cell treatment for people with autoimmune diseases (like lupus or scleroderma) that cause lung scarring and breathing problems. Sixteen adults will receive infusions of donor fat-derived stem cells to see if it is safe and can improve lung function. The goal is to control the disease and reduce the need for stronger medications.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult subjects aged between 20 and 80 years who meet the diagnostic criteria for connective tissue diseases such as dermatomyositis, polymyositis, scleroderma, systemic lupus erythematosus, rheumatoid arthritis, or Sjogren's syndrome. 2. Subjects with refractory or progressive fibrotic interstitial lung disease: Subjects have been treated with steroids and potent immunosuppressants for more than 24 months with continued deterioration of lung function or lung lesions on CT scan (defined as a forced vital capacity (FVC) decline of more than 10% from baseline, an FVC decline of 5-10% with a diffusing capacity for carbon monoxide (DLCO) decline of more than 15% from baseline, or enlargement of lung lesions on CT scan) ; Or subjects with rapidly progressive interstitial lung disease: treated with high-dose steroids (above 0.8 mg/kg/day) and potent immunosuppressants for more than 3 months with continued deterioration of lung function or lung lesions on CT scan (defined as an FVC decline of more than 5% from baseline, a DLCO decline of more than 10% from baseline, or enlargement of lung lesions on CT scan); subjects with rapidly worsening condition: Onset of pulmonary symptoms within one month, gradual worsening of dyspnea and decreased blood oxygen levels, or enlargement of lung lesions. 3. Subjects must have a well-established family support system confirmed by interviews with the principal investigator and social worker. 4. Negative high-sensitivity urine pregnancy test before the trial. 5. Agree to use effective contraceptive measures during the trial (e.g., taking contraceptive pills or using intrauterine devices one month before the trial). Exclusion Criteria: 1. Subjects who are unwilling to sign the informed consent form after detailed explanation by the physician. 2. Patients younger than 20 or older than 80 years who show improvement in lung function or lung lesions on CT scan after 6 months of treatment with steroids and immunosuppressants. 3. Women who are pregnant or breastfeeding, and women of childbearing age who do not use contraception. 4. Subjects with abnormal liver function (serum GOT and GPT levels more than twice the upper limit of 40 units, except those caused by inflammatory myopathy) or poor kidney function (serum creatinine levels exceeding 1.4 units). 5. Subjects with immune deficiencies such as HIV/AIDS or other specific conditions (e.g., those diagnosed with notifiable infectious diseases as per Ministry of Health announcements).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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China Medical University Hospital
RECRUITINGTaichung, 404327, Taiwan
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