Safety and Efficacy of Diverse Mesenchymal Stem Cells Transplantation for Liver Failure
- Conditions
- Liver Failure
- Interventions
- Drug: Conventional treatmentGenetic: Conventional plus BM-MSC treatmentGenetic: Conventional plus UC-MSC treatment
- Registration Number
- NCT01844063
- Lead Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 210
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional treatment Conventional treatment Participants will receive conventional treatment and then be followed until the week 72 study visit. Conventional plus BM-MSC treatment Conventional plus BM-MSC treatment 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. Conventional plus UC-MSC treatment Conventional plus UC-MSC treatment 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.
- Primary Outcome Measures
Name Time Method survival rate 72 weeks The survival rate and time
- Secondary Outcome Measures
Name Time Method Liver function 72 weeks after treatment The levels of serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST),Cholinesterase (CHE) ,Total Bilirubin(TB),Direct Bilirubin(DB), Serum Albumin （ALB）
Marker of liver cancer 72 weeks after treatment The level of alpha-fetoprotein (AFP)
The degree of hepatic necrosis 2 years after treatment The levels of Prothrombin Activity (PA) and Prothrombin Time (PT)
The improvement of symptoms 72 weeks after treatment The improvement of clinical symptoms \[including appetite, debilitation, abdominal distension, edema of lower limbs, et al
The score for Model for End-Stage Liver Disease 72 weeks after treatment The improvement of immune function 72 weeks after treatment cluster of differentiation 4 (CD4+)T/ cluster of differentiation 8 (CD8+)T,T helper cell 1 (Th1)/ T helper cell 1(Th2),natural killer cell(NK),natural killer T(NK T),interleukin-1β(IL-1β),interleukin-4(IL-4),interleukin-6(IL-6),interleukin-8(IL-8),interleukin-12(IL-12),interleukin-15(IL-15),interleukin-17A(IL-17A),Tumor necrosis factor-alpha (TNF-α),Interferon-gamma (IFN-γ)
complications Between 0 to 8 hours after MSC transfusion The occurrence of complications \[including body temperature, tetter and allergy\]
The incidence of hepatocellular carcinoma 72 weeks after treatment
Trial Locations
- Locations (1)
Qi Zhang
🇨🇳Guangzhou, Guangdong, China