Human Umbilical Cord Mesenchymal Stem Cells Treatment in Sepsis
NCT ID: NCT06882811
Last Updated: 2025-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
180 participants
INTERVENTIONAL
2025-05-22
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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135 patients are infused with 1×10⁸ stem cells per session
CD83-positive MSC
90 patients are infused with 1×10⁸ stem cells per session and receive regulatory treatment
regulatory MSC
45 patients are infused with 1×10⁸ stem cells per session and receive regulatory treatment
45 patients are infused with equal volume of control solution
control solution
45 patients are infused with equal volume of control solution and receive regulatory treatment
Interventions
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CD83-positive MSC
90 patients are infused with 1×10⁸ stem cells per session and receive regulatory treatment
regulatory MSC
45 patients are infused with 1×10⁸ stem cells per session and receive regulatory treatment
control solution
45 patients are infused with equal volume of control solution and receive regulatory treatment
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of sepsis (based on Sepsis 3.0 International Guidelines)
* Confirmed or suspected infection
Exclusion Criteria
* 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
0 Years
65 Years
ALL
No
Sponsors
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Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
OTHER
Responsible Party
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xu xiang
Professor
Locations
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Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Fry DE. Sepsis, systemic inflammatory response, and multiple organ dysfunction: the mystery continues. Am Surg. 2012 Jan;78(1):1-8.
Other Identifiers
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2024404
Identifier Type: -
Identifier Source: org_study_id
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