Menu
Recruiting NCT06882811

Human Umbilical Cord Mesenchymal Stem Cells Treatment in Sepsis

Early Phase I Interventional Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CD83-positive MSC, regulatory MSC, control solution.
Who it may be relevant to
Registry conditions: Sepsis. Basic parameters: 0 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Biological CD83-positive MSC
    90 patients are infused with 1×10⁸ stem cells per session and receive regulatory treatment
  • Biological regulatory MSC
    45 patients are infused with 1×10⁸ stem cells per session and receive regulatory treatment
  • Other control solution
    45 patients are infused with equal volume of control solution and receive regulatory treatment

Primary outcome measures

  • 28-day survival rate [Time frame: 28 days]

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:
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Daping Hospital and the Research Institute of Surgery of the Third Military Medical Univer — Chongqing

Publications

  • He X, Ai S, Guo W, Yang Y, Wang Z, Jiang D, Xu X. Umbilical cord-derived mesenchymal stem (stromal) cells for treatment of severe sepsis: aphase 1 clinical trial. Transl Res. 2018 Sep;199:52-61. doi: 10.1016/j.trsl.2018.04.006. Epub 2018 Apr 30. PMID 30044959
  • Li Z, Song Y, Yuan P, Guo W, Hu X, Xing W, Ao L, Tan Y, Wu X, Ao X, He X, Jiang D, Liang H, Xu X. Antibacterial Fusion Protein BPI21/LL-37 Modification Enhances the Therapeutic Efficacy of hUC-MSCs in Sepsis. Mol Ther. 2020 Aug 5;28(8):1806-1817. doi: 10.1016/j.ymthe.2020.05.014. Epub 2020 May 15. PMID 32445625
  • Nemeth K, Leelahavanichkul A, Yuen PS, Mayer B, Parmelee A, Doi K, Robey PG, Leelahavanichkul K, Koller BH, Brown JM, Hu X, Jelinek I, Star RA, Mezey E. Bone marrow stromal cells attenuate sepsis via prostaglandin E(2)-dependent reprogramming of host macrophages to increase their interleukin-10 production. Nat Med. 2009 Jan;15(1):42-9. doi: 10.1038/nm.1905. Epub 2008 Nov 21. PMID 19098906
  • Yagi H, Soto-Gutierrez A, Kitagawa Y, Tilles AW, Tompkins RG, Yarmush ML. Bone marrow mesenchymal stromal cells attenuate organ injury induced by LPS and burn. Cell Transplant. 2010;19(6):823-30. doi: 10.3727/096368910X508942. Epub 2010 Jun 23. PMID 20573305
  • Wannemuehler TJ, Manukyan MC, Brewster BD, Rouch J, Poynter JA, Wang Y, Meldrum DR. Advances in mesenchymal stem cell research in sepsis. J Surg Res. 2012 Mar;173(1):113-26. doi: 10.1016/j.jss.2011.09.053. Epub 2011 Oct 24. PMID 22225756
  • Jin HJ, Bae YK, Kim M, Kwon SJ, Jeon HB, Choi SJ, Kim SW, Yang YS, Oh W, Chang JW. Comparative analysis of human mesenchymal stem cells from bone marrow, adipose tissue, and umbilical cord blood as sources of cell therapy. Int J Mol Sci. 2013 Sep 3;14(9):17986-8001. doi: 10.3390/ijms140917986. PMID 24005862
  • Yi T, Song SU. Immunomodulatory properties of mesenchymal stem cells and their therapeutic applications. Arch Pharm Res. 2012 Feb;35(2):213-21. doi: 10.1007/s12272-012-0202-z. Epub 2012 Feb 28. PMID 22370776
  • Akiyama K, Chen C, Wang D, Xu X, Qu C, Yamaza T, Cai T, Chen W, Sun L, Shi S. Mesenchymal-stem-cell-induced immunoregulation involves FAS-ligand-/FAS-mediated T cell apoptosis. Cell Stem Cell. 2012 May 4;10(5):544-55. doi: 10.1016/j.stem.2012.03.007. Epub 2012 Apr 26. PMID 22542159

Identifiers

NCT: NCT06882811 · 2024404

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗