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Human Umbilical Cord Mesenchymal Stem Cells Treatment in Sepsis

Human Umbilical Cord Mesenchymal Stem Cells Treatment in Sepsis

Recruiting
65 years and younger
All
Phase N/A

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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:
    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

Study details
    Sepsis

NCT06882811

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

15 October 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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