ADSCs Therapy in Patients With CTD-ILD

Phase 1

Recruiting

• Conditions: Connective Tissue Diseases; Interstitial Lung Disease

• Registration Number: NCT06574581
• Lead Sponsor: China Medical University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-1
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Adult subjects aged between 20 and 80 years who meet the diagnostic criteria for<br> connective tissue diseases such as dermatomyositis, polymyositis, scleroderma,<br> systemic lupus erythematosus, rheumatoid arthritis, or Sjogren's syndrome.<br><br> 2. Subjects with refractory or progressive fibrotic interstitial lung disease: Subjects<br> have been treated with steroids and potent immunosuppressants for more than 24<br> months with continued deterioration of lung function or lung lesions on CT scan<br> (defined as a forced vital capacity (FVC) decline of more than 10% from baseline, an<br> FVC decline of 5-10% with a diffusing capacity for carbon monoxide (DLCO) decline of<br> more than 15% from baseline, or enlargement of lung lesions on CT scan) ; Or<br> subjects with rapidly progressive interstitial lung disease: treated with high-dose<br> steroids (above 0.8 mg/kg/day) and potent immunosuppressants for more than 3 months<br> with continued deterioration of lung function or lung lesions on CT scan (defined as<br> an FVC decline of more than 5% from baseline, a DLCO decline of more than 10% from<br> baseline, or enlargement of lung lesions on CT scan); subjects with rapidly<br> worsening condition: Onset of pulmonary symptoms within one month, gradual worsening<br> of dyspnea and decreased blood oxygen levels, or enlargement of lung lesions.<br><br> 3. Subjects must have a well-established family support system confirmed by interviews<br> with the principal investigator and social worker.<br><br> 4. Negative high-sensitivity urine pregnancy test before the trial.<br><br> 5. Agree to use effective contraceptive measures during the trial (e.g., taking<br> contraceptive pills or using intrauterine devices one month before the trial).<br><br>Exclusion Criteria:<br><br> 1. Subjects who are unwilling to sign the informed consent form after detailed<br> explanation by the physician.<br><br> 2. Patients younger than 20 or older than 80 years who show improvement in lung<br> function or lung lesions on CT scan after 6 months of treatment with steroids and<br> immunosuppressants.<br><br> 3. Women who are pregnant or breastfeeding, and women of childbearing age who do not<br> use contraception.<br><br> 4. Subjects with abnormal liver function (serum GOT and GPT levels more than twice the<br> upper limit of 40 units, except those caused by inflammatory myopathy) or poor<br> kidney function (serum creatinine levels exceeding 1.4 units).<br><br> 5. Subjects with immune deficiencies such as HIV/AIDS or other specific conditions<br> (e.g., those diagnosed with notifiable infectious diseases as per Ministry of Health<br> announcements).

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety profile (between the first infusion of AD-MSCs and 48 weeks after the last infusion of AD-MSCs)

Secondary Outcome Measures

Name	Time	Method
Efficacy profile (between the first infusion of AD-MSCs and 48 weeks after the last infusion of AD-MSCs)