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NCT Number: NCT06882811

Human Umbilical Cord Mesenchymal Stem Cells Treatment in Sepsis

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

0 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

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

Chongqing, Chongqing Municipality, 400010, China

Location status: Recruiting

Location contact

Xiang Xu, Doctor of Medicine

CONTACT

[email protected]

+8613637843870

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Treatment and study plan

CD83-positive MSC

Biological

90 patients are infused with 1×10⁸ stem cells per session and receive regulatory treatment

regulatory MSC

Biological

45 patients are infused with 1×10⁸ stem cells per session and receive regulatory treatment

Control Solution

Other

45 patients are infused with equal volume of control solution and receive regulatory treatment

Primary outcomes

  1. 28-day survival rate

    Time frame: 28 days

Study contacts

Contact information is provided by the study sponsor or research team.

Xiang Xu, Professor

CONTACT

[email protected]

+8613637843870

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Clinical Study on Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Sepsis

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 19, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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