Trials / Unknown
UnknownNCT01844063
Safety and Efficacy of Diverse Mesenchymal Stem Cells Transplantation for Liver Failure
Clinical Comparison of Safety and Efficacy of Allogeneic Umbilical-Cord and Bone Marrow-derived Mesenchymal Stem Cells Transplantation for HBV-related Liver Failure
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
HBV-related liver failure (HBV-LF), a dramatic clinical syndrome, is characterized with massive necrosis of liver cells. Liver transplantation might be the most effective therapy for HBV-LF. However, there are a lot of problems such as lack of donors, surgical complications, transplant rejection, and high cost, which could limit the application of liver transplantation. It is demonstrated that mesenchymal stem cells could directionally differentiate into hepatocytes and cholangiocytes in injured liver, as well as reduce inflammation of the liver by immune regulation. In this study, we assess the safety and efficacy of human bone marrow and umbilical cord mesenchymal stem cells transplantation for patients with HBV-LF.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | Conventional plus BM-MSC treatment | Received conventional treatment and bone marrow mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×10e5/Kg,1×10e6/Kg,or 1×10e7/Kg, once a week, 8 times). |
| GENETIC | Conventional plus UC-MSC treatment | Received conventional treatment and bone marrow mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×10e5/Kg,1×10e6/Kg,or 1×10e7/Kg, once a week, 8 times) |
| DRUG | Conventional treatment | Received conventional treatment including: A.antiviral drugs(Entecavir,Lamivudine,Adefovir dipivoxil,et al); B.Hepatoprotective drugs(Ademetionine1,4-butanethiosulfonate for Injection, Reduced Glutathione for Injection,Polyene Phosphatidylcholine, et al); C.Plasma. |
Timeline
- Start date
- 2013-07-01
- Primary completion
- 2016-01-01
- Completion
- 2019-01-01
- First posted
- 2013-05-01
- Last updated
- 2013-07-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01844063. Inclusion in this directory is not an endorsement.