Status:
RECRUITING
Nebulized MSC-Exos for Anti-MDA5+ RP-ILD: Safety and Efficacy Trial
Lead Sponsor:
Li Shiyue
Conditions:
Anti-MDA5 Positive Dermatomyositis-Associated RP-ILD
Rapidly Progressive Interstitial Lung Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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-IL...
Detailed Description
This single-center, prospective interventional trial aims to evaluate the safety profile and potential efficacy of nebulized mesenchymal stem cell-derived exosomes (MSC-exos-P1) in anti-MDA5 positive ...
Eligibility Criteria
Inclusion
- Patients are eligible for inclusion if they meet all of the following criteria:
- Positive for anti-MDA5 antibody dermatomyositis (according to the "Chinese Expert Consensus on the Diagnosis and Treatment of Anti-MDA5 Positive Dermatomyositis (2023 Edition)");
- Pulmonary lesions meet the diagnostic criteria for RP-ILD.
Exclusion
- Patients who meet any of the following criteria will be excluded from this study:
- Pregnant or breastfeeding women, or women planning pregnancy during the study, or men unwilling to use contraceptive measures throughout the trial period;
- History of severe allergies or allergies to the main active ingredients of the trial medication;
- Currently suffering from severe pulmonary infections, pneumothorax, or large pleural effusions;
- Currently diagnosed with pulmonary embolism;
- Currently undergoing mechanical ventilation through tracheal intubation;
- Currently undergoing extracorporeal life support treatments such as ECMO, CRRT, PMX-DHP, or plasma exchange;
- Currently suffering from severe heart failure, liver, or kidney insufficiency;
- Expected to undergo lung transplantation in the near future;
- Currently suffering from lung cancer or pulmonary nodules suspected to be early-stage lung cancer;
- Suffering from primary immunodeficiency diseases;
- 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;
- 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;
- 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.
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06919380
Start Date
April 15 2025
End Date
May 31 2027
Last Update
April 10 2025
Active Locations (1)
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1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510150