Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Phase
Phase EARLY_PHASE1
Started
2025-05-22
Last updated
2025-05-25
Condition(s) studied
Sepsis
Investigational drug(s) / intervention(s)
CD83-positive MSCregulatory MSCcontrol solution
CD83-positive MSC: 90 patients are infused with 1×10⁸ stem cells per session and receive regulatory treatment
regulatory MSC: 45 patients are infused with 1×10⁸ stem cells per session and receive regulatory treatment
control solution: 45 patients are infused with equal volume of control solution and receive regulatory treatment
Study 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.
Eligibility
Sex
ALL
Min age
0 Years
Max age
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
Primary outcome measure(s)
28-day survival rate — 28 days
Trial sites (1)
Facility
City
Region
Status
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing
Chongqing Municipality
Recruiting
More Daping Hospital and the Research Institute of Surgery of the Third Military Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.