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.
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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