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NCT05881668
MSC-EV in Acute-on-Chronic Liver Failure After Liver Transplantation
Phase 1 trial testing MSC-EV in Liver Failure, Acute on Chronic. Withdrawn.
30 September 2024
Quick facts
| Lead sponsor | Third Affiliated Hospital, Sun Yat-Sen University |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 30 September 2023 |
| Primary completion | 30 September 2024 |
| Estimated completion | 30 April 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- MSC-EV — full drug profile →
Conditions studied
- Liver Failure, Acute on Chronic — all drugs for Liver Failure, Acute on Chronic →
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Who can join
Adults 18 to 60, any sex, with Liver Failure, Acute on Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Acute-on-chronic liver failure refers to a liver failure syndrome in which some patients with chronic liver disease with relatively stable liver function suffer from acute liver decompensation and liver failure due to the effects of various acute injury factors. Liver transplantation is the only curative treatment for this type of end-stage liver disease. The potential of MSCs to repair or regenerate damaged tissue and suppress immune responses makes them promising in the treatment of liver diseases, especially in the field of liver transplantation. Many studies have shown that MSC-based therapies can reduce the symptoms of liver disease due to their paracrine effects. Therefore, compared to the cells they derive from, mesenchymal stem cells-derived extracellular vesicles (MSC-EV) are gradually gaining attention for their enhanced safety, as they do not replicate or cause microvascular embolism, and can be easily stored without losing their properties. It represents a novel and effective cell-free therapeutic agent as alternative to cell-based therapies for liver diseases, and liver failure was also concerned. This study was designed to evaluate the safety and tolerability of MSC-EV in acute-on-chronic liver failure after liver transplantation.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Defining tropism and activity of natural and engineered extracellular vesicles.
Choi W, Park DJ, Eliceiri BP. · · 2024 · cited 18× · PMID 38660297 · DOI 10.3389/fimmu.2024.1363185 -
Advances in the application of extracellular vesicles derived from three-dimensional culture of stem cells.
Chen W, Wu P, Jin C, Chen Y, et al · · 2024 · cited 15× · PMID 38693585 · DOI 10.1186/s12951-024-02455-y -
Mesenchymal stem cell therapy as a game-changer in liver diseases: review of current clinical trials.
Huang WC, Li YC, Chen PX, Ma KS, et al · · 2025 · cited 14× · PMID 39762946 · DOI 10.1186/s13287-024-04127-y -
Extracellular vesicle-mediated approaches for the diagnosis and therapy of MASLD: current advances and future prospective.
Gurjar S, Bhat A R, Upadhya R, Shenoy RP. · · 2025 · cited 10× · PMID 39773634 · DOI 10.1186/s12944-024-02396-3 -
Mesenchymal Stromal Cells-Derived Extracellular Vesicles as Potential Treatments for Osteoarthritis.
Yuan S, Li G, Zhang J, Chen X, et al · · 2023 · cited 10× · PMID 37514001 · DOI 10.3390/pharmaceutics15071814 -
Mesenchymal Stem Cell-Derived Exosomes: Emerging as a Promising Cell-Free Therapeutic Strategy for Autoimmune Hepatitis.
Wu L, Zhang L, Huang M, Wu Y, et al · · 2024 · cited 9× · PMID 39595530 · DOI 10.3390/biom14111353 -
Therapeutic Potential of Stem Cell-Derived Extracellular Vesicles in Liver Injury.
Dong J, Luo Y, Gao Y. · · 2024 · cited 2× · PMID 39595055 · DOI 10.3390/biomedicines12112489 -
Bioengineered extracellular vesicles: The path to precision medicine in liver diseases.
Mittal A, Jakhmola VR, Baweja S. · · 2025 · cited 1× · PMID 40206438 · DOI 10.1016/j.livres.2025.02.002
Verify or expand the search:
- PubMed search for NCT05881668
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05881668 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Third Affiliated Hospital, Sun Yat-Sen University
- Last refreshed: 12 October 2023
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