Nebulized MSC-Exos for Anti-MDA5+ RP-ILD: Safety and Efficacy Trial
Key facts
- Phase
- Phase 1
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06919380, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Li Shiyue
- Trial code
- NCT06919380
- Record updated
- 10 April 2025
- Original description
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).Read full original descriptionShow less
Safety and Efficacy Study of Nebulized Mesenchymal Stem Cell-Derived Exosomes (MSC-exos) for the Treatment of Anti-MDA5 Positive Dermatomyositis-Associated Rapidly Progressive Interstitial Lung Disease (RP-ILD)
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, oxygenation index, and pulmonary function tests. Follow-ups at multiple points up to 12 months.
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.