Human Umbilical Cord Mesenchymal Stem Cells Treatment in Sepsis

NCT06882811 | Recruiting Early Phase 1 DMC

• 1 other identifier: 2024404
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• 28-day survival rate

  28 days

Study Arms (2)

135 patients are infused with 1×10⁸ stem cells per session

EXPERIMENTAL

Biological: CD83-positive MSC; Biological: regulatory MSC

45 patients are infused with equal volume of control solution

SHAM COMPARATOR

Other: control solution

Interventions

CD83-positive MSC BIOLOGICAL

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

135 patients are infused with 1×10⁸ stem cells per session

regulatory MSC BIOLOGICAL

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

135 patients are infused with 1×10⁸ stem cells per session

control solution OTHER

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

45 patients are infused with equal volume of control solution

Eligibility Criteria

• Age: 0 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 0-65 years old, diagnosed with sepsis
• Clinical diagnosis of sepsis (based on Sepsis 3.0 International Guidelines)
• Confirmed or suspected infection

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

Related Publications (13)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Gangji V, Hauzeur JP. Cellular-based therapy for osteonecrosis. Orthop Clin North Am. 2009 Apr;40(2):213-21. doi: 10.1016/j.ocl.2008.10.009.

  PMID: 19358906 BACKGROUND

• Phinney DG, Di Giuseppe M, Njah J, Sala E, Shiva S, St Croix CM, Stolz DB, Watkins SC, Di YP, Leikauf GD, Kolls J, Riches DW, Deiuliis G, Kaminski N, Boregowda SV, McKenna DH, Ortiz LA. Mesenchymal stem cells use extracellular vesicles to outsource mitophagy and shuttle microRNAs. Nat Commun. 2015 Oct 7;6:8472. doi: 10.1038/ncomms9472.

  PMID: 26442449 BACKGROUND

• Kaya S. Adventure of recombinant human activated protein C in sepsis and new treatment hopes on the horizon. Recent Pat Inflamm Allergy Drug Discov. 2012 May;6(2):159-64. doi: 10.2174/187221312800166822.

  PMID: 22292553 BACKGROUND

• Wiessner WH, Casey LC, Zbilut JP. Treatment of sepsis and septic shock: a review. Heart Lung. 1995 Sep-Oct;24(5):380-92; quiz 392-3. doi: 10.1016/s0147-9563(05)80059-7.

  PMID: 8567303 BACKGROUND

• Fry DE. Sepsis, systemic inflammatory response, and multiple organ dysfunction: the mystery continues. Am Surg. 2012 Jan;78(1):1-8.

  PMID: 22273282 BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xiang Xu, Professor

CONTACT

+8613637843870; xiangxu@tmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 19, 2025
• Study Start: May 22, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)