Actively Recruiting
Nebulized MSC-Exos for Anti-MDA5+ RP-ILD: Safety and Efficacy Trial
Led by Li Shiyue · Updated on 2025-04-10
10
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nebulized MSC-Exos for Anti-MDA5+ RP-ILD: Safety and Efficacy Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Positive for anti-MDA5 antibody dermatomyositis according to Chinese Expert Consensus (2023 Edition)
- Pulmonary lesions meeting diagnostic criteria for rapidly progressive interstitial lung disease (RP-ILD)
You will not qualify if you...
- Pregnant or breastfeeding women, or women planning pregnancy during the study, or men unwilling to use contraception during the trial
- History of severe allergies or allergies to main active ingredients of the trial medication
- Severe pulmonary infections, pneumothorax, or large pleural effusions
- Pulmonary embolism
- Mechanical ventilation via tracheal intubation
- Receiving extracorporeal life support treatments such as ECMO, CRRT, PMX-DHP, or plasma exchange
- Severe heart failure, liver, or kidney insufficiency
- Expected lung transplantation soon
- Lung cancer or suspected early-stage lung cancer pulmonary nodules
- Primary immunodeficiency diseases
- Active infectious diseases including HIV positivity or active tuberculosis, or otherwise unsuitable by investigator
- Use of other trial medications within 28 days before treatment
- Other conditions deemed unsuitable or poor compliance by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510150
Actively Recruiting
Research Team
L
li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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