Actively Recruiting
Allogenic Adipose Tissue Derived-MSCs Therapy in Patients With Connective Tissue Diseases-associated Interstitial Lung Disease (CTD-ILD) Phase I/IIa Clinical Trial
Led by China Medical University Hospital · Updated on 2026-05-13
16
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Connective tissue disease (CTD) is an autoimmune and inflammatory condition often linked with lung inflammation and scarring called interstitial lung disease (ILD). The number of people affected and deaths from CTD-ILD have increased recently. While corticosteroids and strong immunosuppressants help some patients, progressive lung fibrosis can lead to respiratory failure and may require lung transplantation. Stem cell therapy is emerging as a new approach for treating CTD-ILD, with promising reports using stem cells for ILD patients. This Phase I/IIa open-label trial involves intravenous transfusion of allogenic adipose tissue-derived mesenchymal stem cells (AD-MSC) in 10 patients with refractory or rapidly progressive ILD due to CTD. The first 3 participants will receive a low-dose infusion once; if no adverse effects occur after 4 weeks, the next 4 to 7 participants will receive medium-dose infusions twice; if still no adverse effects after 4 weeks, the last 2 to 3 participants will receive high-dose infusions three times. The goal is to improve outcomes and find the best dose of AD-MSC therapy. Participants will undergo initial evaluations before treatment, receive the stem cell infusions during admission, and then be followed up for safety and effectiveness for 48 weeks after the last infusion. Researchers will monitor safety throughout and assess lung function and other health indicators to evaluate treatment impact. The total study period includes treatment and nearly a year of post-infusion observation to track outcomes and any adverse effects.
CONDITIONS
Brief Title
ADSCs Therapy in Patients With CTD-ILD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 20 to 80 years diagnosed with connective tissue diseases such as dermatomyositis, polymyositis, scleroderma, systemic lupus erythematosus, rheumatoid arthritis, or Sjogren's syndrome.
- Patients with refractory or progressive fibrotic interstitial lung disease treated with steroids and immunosuppressants for over 24 months showing continued lung function decline or worsening lung lesions.
- Patients with rapidly progressive interstitial lung disease treated with high-dose steroids and immunosuppressants for more than 3 months and experiencing worsening lung function or lesions.
- Patients with rapidly worsening lung symptoms starting within one month, including worsening shortness of breath and decreased oxygen levels.
- Patients must have a well-established family support system confirmed by interviews.
- Negative high-sensitivity urine pregnancy test before the trial.
- Agreement to use effective contraception during the trial.
You will not qualify if you...
- Patients unwilling to sign informed consent.
- Patients younger than 20 or older than 80 who show lung improvement after 6 months of steroid and immunosuppressant treatment.
- Women who are pregnant, breastfeeding, or of childbearing age not using contraception.
- Patients with abnormal liver function or poor kidney function beyond specified limits.
- Patients with immune deficiencies such as HIV/AIDS or certain notifiable infectious diseases.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks depending on dosing schedule
Participants receive intravenous infusions of allogenic adipose tissue derived mesenchymal stem cells (AD-MSCs) in up to three doses depending on cohort assignment: one infusion for the first 3 participants, two infusions for the next 4-7 participants, and three infusions for the last 8-10 participants.
1 to 3 infusion visits depending on cohort assignment
Duration - 48 weeks after last infusion
Participants are monitored for safety and efficacy for up to 48 weeks after the last infusion of AD-MSCs.
Regular follow-up visits during the 48-week monitoring period
Trial Site Locations
Total: 1 location
1
China Medical University Hospital
Taichung, Taiwan, 404327
Actively Recruiting
Research Team
D
Der-Yuan Chen, M.D.;Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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