Overview
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
Inclusion Criteria:
- Age: 0-65 years old, diagnosed with sepsis
- Clinical diagnosis of sepsis (based on Sepsis 3.0 International Guidelines)
- Confirmed or suspected infection
Exclusion Criteria:
- Violation of medical ethics
- Significant confounding factors likely to bias study outcomes
- Poor adherence to the study protocol
- Concurrent participation in other clinical trials
- Specific medical conditions:
- History of chronic enteritis, neuropsychiatric disorders, or transplantation (bone marrow, lung, liver, pancreas, or small intestine)
- Severe primary diseases affecting survival (e.g., life-limiting hepatic, renal, or endocrine disorders) or psychiatric disorders
- History of hypersensitivity or severe adverse reactions to biological products
- Imminent terminal status (e.g., septic shock, life expectancy <7 days)
- Foreseeable risk of medical errors or disputes during hospitalization
- Active drug-resistant infections
- History of malignancy at screening
- Pregnancy, lactation, or plans for pregnancy within the next year