Human Umbilical Cord Mesenchymal Stem Cells Treatment in Sepsis

ConditionSepsis
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age0-65
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age: 0-65 years old, diagnosed with sepsis

Clinical diagnosis of sepsis (based on Sepsis 3.0 International Guidelines)

Confirmed or suspected infection

Disqualifiers

Violation of medical ethics

Significant confounding factors likely to bias study outcomes

Poor adherence to the study protocol

Concurrent participation in other clinical trials

Trial design

Design model

Parallel

Treatments tested in this trial

  • CD83-positive MSC

    Biological/Vaccine

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

  • regulatory MSC

    Biological/Vaccine

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

  • control solution

    Other intervention

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

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: 135 patients are infused with 1×10⁸ stem cells per sessionExperimental treatment 2 interventions
Group B: 45 patients are infused with equal volume of control solutionSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

28-day survival rate

Time frame
28 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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