What this Trial Is About

Researchers are evaluating the safety and effectiveness of Menstrual blood-derived Mesenchymal Stem Cells (SC01009) injection combined with standard treatment for patients with severe viral pneumonia, excluding coronavirus infections. Severe viral pneumonia causes lung inflammation and symptoms such as fever, cough, wheezing, and difficulty breathing, often requiring ventilator support. This study is a multicenter, randomized, double-blind, placebo-controlled Phase 1 trial aiming to explore SC01009's potential benefits in treating this serious condition. Participants will receive either the SC01009 injection or a placebo via intravenous infusion on three alternate days (Day 1, Day 3, and Day 5). Each infusion involves thawing and diluting the medication into a solution before slowly administering it over about two hours. All patients will also receive standard treatments like anti-infective, anti-inflammatory, antiviral, and supportive care medications as needed. The placebo is prepared and infused in the same manner to maintain blinding. During the study, participants will be closely monitored for adverse events, infusion reactions, and changes in inflammatory and immune markers for up to three months after treatment. Researchers will also measure pneumonia improvement and mortality rates over 28 days. Assessments include clinical evaluations, laboratory tests, and imaging to ensure safety and track treatment effects. Overall participation spans approximately two years, allowing for long-term observation of outcomes and safety.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Uterine Blood Mesenchymal Stem Cells Injection for the Treatment of Severe Pneumonia Caused by Viruses