Sepsis
Conditions
Brief summary
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.
Interventions
OTHERcontrol solution
45 patients are infused with equal volume of control solution and receive regulatory treatment
BIOLOGICALCD83-positive MSC
90 patients are infused with 1×10⁸ stem cells per session and receive regulatory treatment
BIOLOGICALregulatory MSC
45 patients are infused with 1×10⁸ stem cells per session and receive regulatory treatment
Sponsors
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
0 Years to 65 Years
Healthy volunteers
No
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: 1. History of chronic enteritis, neuropsychiatric disorders, or transplantation (bone marrow, lung, liver, pancreas, or small intestine) 2. Severe primary diseases affecting survival (e.g., life-limiting hepatic, renal, or endocrine disorders) or psychiatric disorders 3. History of hypersensitivity or severe adverse reactions to biological products 4. Imminent terminal status (e.g., septic shock, life expectancy \<7 days) 5. Foreseeable risk of medical errors or disputes during hospitalization 6. Active drug-resistant infections 7. History of malignancy at screening 8. Pregnancy, lactation, or plans for pregnancy within the next year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day survival rate | 28 days |
Countries
China
Contacts
Primary ContactXiang Xu, Professor
Outcome results
None listed