About this trial
The primary objective: To evaluate the efficacy of intravenous infusion of universal UC-MSCs and CD83+MSCs subpopulation injection in the treatment of sepsis by using the 28-day survival rate of the subjects as the primary efficacy criterion.The secondary objectives: 1. To systematically evaluate the safety of universal UC-MSCs and CD83+MSCs subpopulation in the treatment of sepsis; 2. To provide theoretical basis and clinical research data for establishing a safe, effective and feasible clinical treatment plan for sepsis using stem cells.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 0-65 years old, diagnosed with sepsis
Clinical diagnosis of sepsis (based on Sepsis 3.0 International Guidelines)
Confirmed or suspected infection
Disqualifiers
Violation of medical ethics
Significant confounding factors likely to bias study outcomes
Poor adherence to the study protocol
Concurrent participation in other clinical trials
Trial design
Parallel
Treatments tested in this trial
CD83-positive MSC
Biological/Vaccine90 patients are infused with 1×10⁸ stem cells per session and receive regulatory treatment
regulatory MSC
Biological/Vaccine45 patients are infused with 1×10⁸ stem cells per session and receive regulatory treatment
control solution
Other intervention45 patients are infused with equal volume of control solution and receive regulatory treatment
Treatment groups
Trial outcomes
Primary outcomes
28-day survival rate
Sponsors and contacts
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