Human Umbilical Cord Mesenchymal Stem Cells Treatment in Sepsis

May 23, 2025 updated by: xu xiang, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • Recruiting
        • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 135 patients are infused with 1×10⁸ stem cells per session
Biological: regulatory MSC
45 patients are infused with 1×10⁸ stem cells per session and receive regulatory treatment
Biological: CD83-positive MSC
90 patients are infused with 1×10⁸ stem cells per session and receive regulatory treatment
Sham Comparator: 45 patients are infused with equal volume of control solution
Other: control solution
45 patients are infused with equal volume of control solution and receive regulatory treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
28-day survival rate
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 19, 2025

Study Record Updates

Last Update Posted (Actual)

May 25, 2025

Last Update Submitted That Met QC Criteria

May 23, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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