NCT03863002

Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure

Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Tianjin Weikai Bioeng., Ltd. · Industry
• Sex: All
• Age: 16 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure

Detailed description

Acute-on-chronic liver failure (ACLF) which occurs in patients with chronic liver disease, is a serious live-threatening disease. Currently, the clinical management, such as liver protection, anti-virus medicine, and artificial liver support, has not significantly improve the outcomes, the mortality still remains over 50%. Liver transplantation is the only effective treatment of ACLF, but this therapy is limited by the shortage of donor organs, potential surgical complications, immunological rejection and high medical costs. Mesenchymal stem cell (MSC) is one of adult stem cells, which has been suggested to play a role in amelioration of liver disease, such as: trans-differentiation of MSCs into hepatocytes, immunomodulation, inhibition of fibrosis development, protective effects on hepatic cell and restoration of hepatic cell proliferation capacity.

Conditions

• Liver Failure, Acute on Chronic

Interventions

Type	Name	Description
BIOLOGICAL	Mesenchymal Stem Cell	Mesenchymal stem cell transplantation via peripheral vein: 1.0-10x10\^5 MSCs/kg body weight administered via peripheral vein at week 0, 1, 2, 3 weeks

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-10-01
• Completion: 2022-10-01
• First posted: 2019-03-05
• Last updated: 2019-03-20

Locations

1 site across 1 country: China