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Nebulized MSC-Exos for Anti-MDA5+ RP-ILD: Safety and Efficacy Trial

RecruitingPhase 1Ages 18 Years - 75 YearsAllLi Shiyue
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In plain words

What the trial is, and whether it could suit you

Objective: To assess the safety, tolerability, and efficacy of nebulized MSC-exos-P1 in patients with anti-MDA5 positive dermatomyositis-associated rapidly progressive interstitial lung disease (RP-ILD). Design: Prospective interventional trial with 10 eligible patients aged 18-75, meeting criteria for RP-ILD and anti-MDA5 positivity. Primary endpoint is safety and tolerability, measured by adverse events within 30 days post-treatment. Secondary endpoints are clinical improvements on days 14 and 28, including serological indicators and chest HRCT scores. Exclusions: Pregnant/breastfeeding individuals, severe allergies, active pulmonary infections, pulmonary embolism, extracorporeal support treatments, and other specified conditions. Treatment: Nebulized MSC-exos-P1 daily for 14 days, plus standard care of corticosteroids and immunosuppressants. Monitoring: Regular vital signs, oxygen

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients are eligible for inclusion if they meet all of the following criteria: 1. Positive for anti-MDA5 antibody dermatomyositis (according to the "Chinese Expert Consensus on the Diagnosis and Treatment of Anti-MDA5 Positive Dermatomyositis (2023 Edition)"); 2. Pulmonary lesions meet the diagnostic criteria for RP-ILD. Exclusion Criteria: * Patients who meet any of the following criteria will be excluded from this study: 1. Pregnant or breastfeeding women, or women planning pregnancy during the study, or men unwilling to use contraceptive measures throughout the trial period; 2. History of severe allergies or allergies to the main active ingredients of the trial medication; 3. Currently suffering from severe pulmonary infections, pneumothorax, or large pleural effusions; 4. Currently diagnosed with pulmonary embolism; 5. Currently undergoing mechanical ventilation through tracheal intubation; 6. Currently undergoing extracorporeal life support treatments such as ECMO, CRRT, PMX-DHP, or plasma exchange; 7. Currently suffering from severe heart failure, liver, or kidney insufficiency; 8. Expected to undergo lung transplantation in the near future; 9. Currently suffering from lung cancer or pulmonary nodules suspected to be early-stage lung cancer; 10. Suffering from primary immunodeficiency diseases; 11. Currently suffering from active infectious diseases, including but not limited to HIV positivity, active tuberculosis, etc., and deemed unsuitable for this trial by the researcher; 12. Use of other trial medications within 28 days before starting treatment, which the researcher judges may interfere with the safety and efficacy assessment of this trial medication; 13. Other situations deemed not in the best interest of the subject or unsuitable for participation in this study by the researcher, such as poor compliance.
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What it tests

  • MSC-exos Nebulization Therapy
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Where

1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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