Human Umbilical Cord Mesenchymal Stem Cells Treatment in Sepsis

Early Phase 1

Recruiting

• Conditions: Sepsis
• Interventions: Biological: CD83-positive MSC; Other: control solution; Biological: regulatory MSC

• Registration Number: NCT06882811
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-17
• Study First Posted: 2025-03-19
• Status Verified: 2025-05
• Study Start: 2025-05-22
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-25
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
135 patients are infused with 1×10⁸ stem cells per session	CD83-positive MSC	-
135 patients are infused with 1×10⁸ stem cells per session	regulatory MSC	-
45 patients are infused with equal volume of control solution	control solution	-

Primary Outcome Measures

Name	Time	Method
28-day survival rate	28 days

Trial Locations

Locations (1)

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China