Clinical trial NCT06882811: Human Umbilical Cord Mesenchymal Stem Cells Treatment in Sepsis
Official title: Clinical Study on Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Sepsis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Sepsis
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 180
Sex: ALL
Minimum age (years): 0
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: 28-day survival rate
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
state: Chongqing
Study officials:
References:
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