Safety and Efficacy of Diverse Mesenchymal Stem Cells Transplantation for Liver Failure

Sun Yat-sen University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Liver Failure

Treatments: Drug: Conventional treatment; Genetic: Conventional plus UC-MSC treatment; Genetic: Conventional plus BM-MSC treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01844063

The Third Affiliated Hospital

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18-65 years
• Liver failure
• Negative pregnancy test (female patients in fertile age)
• Written consent
• HBsAg positive
• TB≥171 μmol/L or ascend ≥17.1 μmol/L/per day,
• INR≥1.5 or 20%<PTA≤40%
• 17≤MELD score≤30

Exclusion criteria

• Hepatocellular carcinoma or other malignancies
• Severe problems in other vital organs(e.g.the heart,renal or lungs)
• Pregnant or lactating women
• Severe bacteria infection
• Anticipated with difficulty of follow-up observation
• Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on
• Other candidates who are judged to be not applicable to this study by doctors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 3 patient groups

Conventional treatment

Experimental group

Description:

Participants will receive conventional treatment and then be followed until the week 72 study visit.

Treatment:

Drug: Conventional treatment

Conventional plus BM-MSC treatment

Experimental group

Description:

Participants will receive conventional treatment plus a dose of BM-MSC(each subgroups with a different dose ) and then be followed until the week 72 study visit.

Treatment:

Genetic: Conventional plus BM-MSC treatment

Conventional plus UC-MSC treatment

Experimental group

Description:

Participants will receive conventional treatment plus a dose of UC-MSC(each subgroups with a different dose ) and then be followed until the week 72 study visit.

Treatment:

Genetic: Conventional plus UC-MSC treatment