ADSCs Therapy in Patients With CTD-ILD

Launched by CHINA MEDICAL UNIVERSITY HOSPITAL · Aug 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment using stem cells for patients with connective tissue diseases (CTD) that affect the lungs, known as interstitial lung disease (ILD). CTD-ILD can cause serious lung problems, and while some patients improve with traditional treatments like steroids, others continue to get worse. The goal of this trial is to see if stem cell therapy can help those patients who have not responded well to standard treatments.

To participate in the trial, you need to be an adult between the ages of 20 and 80, diagnosed with specific connective tissue diseases such as lupus or rheumatoid arthritis, and have worsening lung issues despite receiving treatment for at least 24 months. Participants will receive close medical supervision and will be supported by a healthcare team throughout the study. Additionally, women who can become pregnant must use effective contraception during the trial. This is an exciting opportunity, as stem cell therapy may offer new hope for patients struggling with severe lung conditions.

Gender

ALL

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).