Using stem cells to treat lung disease in patients with connective tissue disorders

Allogenic Adipose Tissue Derived-MSCs Therapy in Patients With Connective Tissue Diseases-associated Interstitial Lung Disease(CTD-ILD): Phase I/IIa Clinical Trial

This study is testing if a new treatment using stem cells can help improve lung function in patients with lung disease caused by connective tissue disorders.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 20 Years to 80 Years
• Sex: All
• Sponsor: China Medical University Hospital (other)
• Locations: 1 site (Taichung)
• Trial ID: NCT06574581 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of adipose-derived mesenchymal stem cells (AD-MSC) in patients suffering from connective tissue disease-associated interstitial lung disease (CTD-ILD). The study will involve administering intravenous infusions of AD-MSC to patients who have refractory or rapidly progressive forms of ILD. Participants will undergo a series of infusions, with monitoring for adverse events and assessment of lung function over time. The trial is designed to determine whether this innovative stem cell therapy can improve lung function and overall outcomes in affected patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 20 to 80 with diagnosed connective tissue diseases and refractory or rapidly progressive interstitial lung disease.

Not a fit: Patients with stable ILD or those who do not meet the criteria for connective tissue diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option that significantly improves lung function and quality of life for patients with CTD-ILD.

How similar studies have performed: While stem cell therapies have shown promise in treating various autoimmune and lung diseases, this specific approach using AD-MSC for CTD-ILD is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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).

Where this trial is running

Taichung

• China Medical University Hospital — Taichung, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Der-Yuan Chen, M.D.;Ph.D

Conditions: Connective Tissue Diseases, Interstitial Lung Disease