Phase I-II Study of Human Umbilical Cord Mesenchymal Stem Cell Injection for Moderate to Severe Acute Respiratory Distress Syndrome Evaluating Safety, Tolerability, and Dosage

What this Trial Is About

Researchers are studying the safety and tolerability of human umbilical cord mesenchymal stem cell injections for adults aged 18 to 80 with moderate to severe acute respiratory distress syndrome ARDS caused by infection. This Phase I-II open-label trial also explores the appropriate dosage, potential effects on the immune system, and how the treatment behaves in the body over time. Participants receive a single dose of stem cells delivered through a vein, with doses ranging from 5 x 107 to 2 x 108 cells. The study does not include a placebo group and focuses on dose escalation to assess safety. The trial is sponsored by Changchun Tuohua Pharmaceutical Co., Ltd. During the 28 days following treatment, participants will have their vital signs, lab tests, lung function, organ failure status, and oxygen levels monitored regularly. Researchers will track any side effects, mortality rates, and time spent without mechanical ventilation or intensive care. Long-term follow-up is also part of the study to further assess safety and effects.

A Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection for the Treatment of Severe Acute Respiratory Distress Syndrome