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

Launched by LI SHIYUE · Apr 7, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called nebulized MSC-exosomes (MSC-exos-P1) for patients with a specific type of lung disease linked to a condition called anti-MDA5 positive dermatomyositis. This disease is known for causing rapidly progressive lung problems, and the trial aims to find out if this new treatment is safe and effective. The study will involve 10 patients aged 18 to 75 who have been diagnosed with this condition. To participate, patients must test positive for the anti-MDA5 antibody and have lung issues that meet the criteria for rapidly progressive interstitial lung disease.

Participants in the trial will receive the nebulized treatment daily for 14 days, in addition to their standard medications like corticosteroids and immunosuppressants. Throughout the study, their health will be closely monitored, including regular checks on their breathing and overall well-being. This trial is currently recruiting and specifically excludes individuals with certain health issues, such as severe allergies, active infections, or those undergoing specific treatments for other conditions. By the end of the study, researchers hope to gather information on both the safety of the treatment and any improvements in lung function.

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Eligibility criteria

• 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.