Status:
RECRUITING
ADSCs Therapy in Patients With CTD-ILD
Lead Sponsor:
China Medical University Hospital
Conditions:
Connective Tissue Diseases
Interstitial Lung Disease
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Connective tissue disease (CTD), an autoimmune and inflammatory disease, usually accompanied by lung interstitial/alveolar inflammation and fibrosis (so called interstitial lung disease, ILD). The pre...
Detailed Description
Mesenchymal stem cells (MSCs) are adult multipotent cells with self-renewal capacity, and have immunomodulatory function. By virtue of these properties, they have an ability of tissues repairing as we...
Eligibility Criteria
Inclusion
- 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.
- 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.
- Subjects must have a well-established family support system confirmed by interviews with the principal investigator and social worker.
- Negative high-sensitivity urine pregnancy test before the trial.
- Agree to use effective contraceptive measures during the trial (e.g., taking contraceptive pills or using intrauterine devices one month before the trial).
Exclusion
- Subjects who are unwilling to sign the informed consent form after detailed explanation by the physician.
- 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.
- Women who are pregnant or breastfeeding, and women of childbearing age who do not use contraception.
- 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).
- 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).
Key Trial Info
Start Date :
August 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06574581
Start Date
August 20 2024
End Date
May 30 2026
Last Update
August 28 2024
Active Locations (1)
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1
China Medical University Hospital
Taichung, Taiwan, 404327