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

Recruiting Phase 1 Interventional Study
Anti-MDA5 Positive Dermatomyositis-Associated RP-ILD Rapidly Progressive Interstitial Lung Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
10 (estimated)
Sponsor
Li Shiyue · Other
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About This Trial
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 adver…
Trial Locations
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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. Pulmona…
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020-81567301

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