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Clinical Trials in China / NCT06882811
Recruiting Early Phase 1

Human Umbilical Cord Mesenchymal Stem Cells Treatment in Sepsis

NCT06882811 · tracked via the Priya Life Science China tracker
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Phase
Early Phase 1
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)

FacilityCityRegionStatus
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Chongqing Chongqing Municipality Recruiting

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Other trials for the same condition

TRIM25 in Septic Patients Enrolling by invitation
The Impact of Sepsis on Long-term Outcomes in Critical Ill Children With Sepsis Recruiting
Clinical Features and Outcomes of CBP Versus Non-CBP in Septic Children Recruiting
Thymalfasin for Immune Recovery in Adults With Sepsis Recruiting
Gelaspan vs Crystalloid Therapy in Sepsis Recruiting
Official registry record

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.

View NCT06882811 on ClinicalTrials.gov ↗ ← All trials in China