NCT05871463

Effect of Mesenchymal Stem Cells-derived Exosomes in Decompensated Liver Cirrhosis

Status unknown Phase 2 Last updated 23 May 2023

What this trial tests

Phase 2 trial testing MSC-derived exosomes in Decompensated Liver Cirrhosis in 15 participants. Status unknown.

Timeline

26 May 2023

Primary endpoint
11 August 2023

11 December 2023

Quick facts

Lead sponsor	Research Institute for Gastroenterology and Liver Diseases (RIGLD)
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	26 May 2023
Primary completion	11 August 2023
Estimated completion	11 December 2023
Sites	1 location across Iran

Drugs / interventions tested

• MSC-derived exosomes — full drug profile →

Conditions studied

• Decompensated Liver Cirrhosis — all drugs for Decompensated Liver Cirrhosis →

Sponsor

Research Institute for Gastroenterology and Liver Diseases (RIGLD)

Who can join

Adults 18 to 75, any sex, with Decompensated Liver Cirrhosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Decompensated liver cirrhosis (LC), a life-threatening complication of chronic liver disease, is one of the major indications for liver transplantation. Recently, mesenchymal stem cell (MSC) transfusion has been shown to lead to the regression of liver fibrosis in mice and humans. However, little is known about MSC-exosome therapy. We will evaluate the therapeutic potential of mesenchymal stem Cell-Exosomes as an alternative to cell therapy in Cirrhotic patients. This study examined the safety and efficacy of umbilical cord-derived MSC-exosomes in patients with decompensated LC.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical applications of stem cell-derived exosomes.
   Tan F, Li X, Wang Z, Li J, et al · · 2024 · cited 390× · PMID 38212307 · DOI 10.1038/s41392-023-01704-0
2. Biogenesis, Isolation, and Detection of Exosomes and Their Potential in Therapeutics and Diagnostics.
   Sonbhadra S, Mehak, Pandey LM. · · 2023 · cited 51× · PMID 37622888 · DOI 10.3390/bios13080802
3. Insight into the Functional Dynamics and Challenges of Exosomes in Pharmaceutical Innovation and Precision Medicine.
   Sharma A, Yadav A, Nandy A, Ghatak S. · · 2024 · cited 40× · PMID 38931833 · DOI 10.3390/pharmaceutics16060709
4. Understanding molecular characteristics of extracellular vesicles derived from different types of mesenchymal stem cells for therapeutic translation.
   Ding Z, Greenberg ZF, Serafim MF, Ali S, et al · · 2024 · cited 34× · PMID 38957857 · DOI 10.1016/j.vesic.2024.100034
5. Standardized Reporting of Research on Exosomes to Ensure Rigor and Reproducibility.
   Yadav A, Xuan Y, Sen CK, Ghatak S. · · 2024 · cited 28× · PMID 38888007 · DOI 10.1089/wound.2024.0093
6. Stem Cell-Based Acellular Therapy: Insight into Biogenesis, Bioengineering and Therapeutic Applications of Exosomes.
   Choudhery MS, Arif T, Mahmood R, Harris DT. · · 2024 · cited 26× · PMID 39062506 · DOI 10.3390/biom14070792
7. The Opportunities and Challenges of Mesenchymal Stem Cells-Derived Exosomes in Theranostics and Regenerative Medicine.
   Yadav S, Maity P, Kapat K. · · 2024 · cited 19× · PMID 39682706 · DOI 10.3390/cells13231956
8. Stem cell-based therapy for fibrotic diseases: mechanisms and pathways.
   Taherian M, Bayati P, Mojtabavi N. · · 2024 · cited 18× · PMID 38886859 · DOI 10.1186/s13287-024-03782-5