U.S., April 10 -- ClinicalTrials.gov registry received information related to the study (NCT06919380) titled 'Nebulized MSC-Exos for Anti-MDA5+ RP-ILD: Safety and Efficacy Trial' on Feb. 13.
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-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 ...