Status:
RECRUITING
Human Umbilical Cord Mesenchymal Stem Cells Treatment in Sepsis
Lead Sponsor:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Conditions:
Sepsis
Eligibility:
All Genders
Up to 65 years
Phase:
EARLY_PHASE1
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 s...
Eligibility Criteria
Inclusion
- Age: 0-65 years old, diagnosed with sepsis
- Clinical diagnosis of sepsis (based on Sepsis 3.0 International Guidelines)
- Confirmed or suspected infection
Exclusion
- 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
Key Trial Info
Start Date :
May 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06882811
Start Date
May 22 2025
End Date
December 31 2027
Last Update
May 25 2025
Active Locations (1)
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1
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, China, 400010