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SepsisEarly Phase 1NCT06882811

Human Umbilical Cord Mesenchymal Stem Cells Treatment in Sepsis

A Early Phase 1 study testing CD83-positive MSC and regulatory MSC in people with Sepsis, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 0 to 65 years
Conditions the study is for
Sepsis
What is being tested?
CD83-positive MSC and regulatory MSC
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteChina
Study dates
22 May 2025to 31 Dec 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiang Xu, Professor contact

+8613637843870

xiangxu@tmmu.edu.cn

China1 site, 1 recruiting

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

    Chongqing, Chongqing Municipality, 400010

    Xiang Xu, Doctor of Medicine, +8613637843870, xiangxu@tmmu.edu.cn

    Recruiting

Other trials in China

About this study

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

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
Being tested
CD83-positive MSC, regulatory MSC, control solution
Medical subject headings
Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD83-positive MSCBiological

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

  • regulatory MSCBiological

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

  • control solutionOther

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

Study groups in NCT06882811
Study groupRoleWhat they receive
135 patients are infused with 1×10⁸ stem cells per sessionExperimentalNot described
Receives: Biological: CD83-positive MSC; Biological: regulatory MSC
45 patients are infused with equal volume of control solutionSham comparatorNot described
Receives: Other: control solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 28-day survival rate

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2025
  2. Study start22 May 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06882811
Sponsor's protocol ID
2024404
Status last verified
May 2025
First submitted
17 Mar 2025
Last updated
25 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 22542159

  • 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.

    PubMed 19358906

  • 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.

    PubMed 26442449

  • 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.

    PubMed 22292553

  • 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.

    PubMed 8567303

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

    PubMed 22273282

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CD83-positive MSC and regulatory MSC in people with Sepsis, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiang Xu, Professor (+8613637843870, xiangxu@tmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

28-day survival rate (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06882811, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.

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