Liver Cirrhosis | ABMSC Infusion Through Hepatic Artery in Portal Hypertension Surgery for the Treatment of Liver Cirrhosis
Liver Cirrhosis research study
What is the primary objective of this study?
In recent years, the safety and efficacy of autologous bone marrow stem cells infusion (ABMSCi) therapy were confirmed. The investigators attempted to infuse autologous bone marrow stem cells (ABMSC) through inserting a catheter into right gastric artery as far as proper hepatic artery after finishing open abdominal portal hypertension surgery. The present study was designed to treat bleeding from esophageal varices and hypersplenism and hopefully to improve the liver function as well.
Who is eligible to participate?
Inclusion Criteria: 1. Advanced liver cirrhosis after hepatitis B resulted in bleeding from esophageal varices and hypersplenism, and needed open abdominal portal hypertension surgery; 2. Endoscopy evidence of showing severe gastric and esophageal varices; 3. Severe hypersplenism （white blood cells (WBC) <3×109/L and platelet (PLT) <100×109/L）; 4. Active bone marrow hyperplasia showed by bone marrow biopsy before surgery; 5. Age between 18 and 60 years; 6. Plasma albumin <35g/L, or mild ascites; Exclusion Criteria: 1. Enlisted for liver transplantation 2. Diagnosis of hepatocellular carcinoma or other cancers 3. Other severe medical disease, and acute infection.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:Autologous bone marrow stem cells infusion （ABMSCi） plus abdominal portal hypertension surgeryImmediately after the harvest of ABMSC, the modified Sugiura procedure was performed for the patients who were assigned to the study group. The time of ABMSC separation and purification was 2.5-3 hours which had to be completed before the conclusion of portal hypertension surgery (3-3.5 hours). ABMSC was infused into proper hepatic artery through right gastric artery during the portal hypertension surgery
Procedure:open abdominal portal hypertension surgerythe modified Sugiura procedure was performed for the patients
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ABMSCi plus surgery groupAutologous bone marrow stem cells infusion through hepatic artery in open abdominal portal hypertension surgery
portal hypertension surgery grouponly portal hypertension surgery for this group patients
Start Date: June 2010
Completed Date: June 2014
Phase: Phase 2/Phase 3
Primary Outcome: Child-pugh score
Secondary Outcome: Incidence of complications
Study sponsors, principal investigator, and references
Principal Investigator: qiyu zhang, MD
Lead Sponsor: Wenzhou Medical University
am Esch JS, Schmelzle M, Fürst G, Robson SC, Krieg A, Duhme C, Tustas RY, Alexander A, Klein HM, Topp SA, Bode JG, Häussinger D, Eisenberger CF, Knoefel WT. Infusion of CD133+ bone marrow-derived stem cells after selective portal vein embolization enhances functional hepatic reserves after extended right hepatectomy: a retrospective single-center study. Ann Surg. 2012 Jan;255(1):79-85. doi: 10.1097/SLA.0b013e31823d7d08.