A Phase 1/2 interventional study of Conventional plus MSC treatment and Conventional plus pacebo treatment in Liver Failure and Mesenchymal Stem Cells, sponsored by Beijing 302 Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-05-31.
Sponsored by Beijing 302 Hospital · Phase 1/2, Interventional, and Treatment
Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. and liver transplantation is the only available therapeutic option for patients suffering with this condition. However, lack of donors, surgical complications, rejection, and high cost are serious problems. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. In this study, the patients with LF will undergo administration of human umbilical cord mesenchymal stem cells (UC-MSCs) via peripheral vein transfusion to evaluate the safty and efficacy of UC-MSCs treatment for these patients.
Liver failure (LF) is a severe life-threatening condition, and is a dramatic clinical syndrome with massive necrosis of liver cells, and liver transplantation is the only available therapeutic option for patients suffering with this condition. However, lack of donors, surgical complications, rejection, and high cost are serious problems. Since current therapeutic options for LF that is usually with extremely poor prognosis are still limited, recent studies indicate that mesenchymal stem cells (MSCs), due to their function in immune modulation and liver-damage repair, are of great therapeutic potential for this disease. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration.The purpose of this study is to investigate the safety and initial efficacy of human umbilical cord MSC (UC-MSCs) treatment for patients with LF. In this study, MSCs were isolated from umbilical cord and generated in appropriate growth medium. 50 LF patients with LF received i.v. transfusion of 0.5-1.0×106 cells/kg of MSCs as the treated group and other 20 LF patients with LF were transfused with placebo without MSCs as control group. All 70 of them received the routine management for liver failure. During the 2-year follow up, the evaluation of safty and efficacy will be undergone to help to establish innovative cell-based therapies for the treatment of diseases.
445 studies on the registry are indexed under Liver Failure; 69 are open to participants now.
This study's planned enrollment of 70 is above the median of 43 across 276 interventional studies indexed under Liver Failure.
Browse Liver Failure studies →Beijing 302 Hospital is the lead sponsor of 86 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
Participants will receive conventional treatment plus a dose of MSC from day 0 through the week 12 study visit. Participants will then be followed until 2 years study visit
Drug: Conventional plus MSC treatment
Participants will receive conventional plus placebo treatment from day 0 through the week 12 study visit. Participants will then be followed until 2 years study visit
Drug: Conventional plus pacebo treatment
Participants received conventional treatment and taken i.v., once per 4 week, at a dose of 0.5\*10E6 MSC/kg body for 12 weeks.
Participants received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 12 weeks.
The levels of serum Total Protein and Albumin
Time frame: 2 years after treatment
The levels of serum Total Bilirubin and Direct Bilirubin
Time frame: 2 years after treatment
The levels of serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Cholinesterase (CHE)
Time frame: 2 years after treatment
The level of alpha-fetoprotein (AFP)
Time frame: 2 years after treatment
The content of ascites
Time frame: 2 years after treatment
Survival rate and time
Time frame: 2 years after treatment
Body temperature, tetter and allergy
Time frame: Between 0 to 24 hours after UC-MSCs transfusion
The levels of Prothrombin Activity (PA) and Prothrombin Time (PT)
Time frame: 2 years after treatment
The score for Model for End-Stage Liver Disease
Time frame: 2 years after treatment
This study is status unknown, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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Beijing 302 Hospital