ABMSC Infusion Through Hepatic Artery in Portal Hypertension Surgery for the Treatment of Liver Cirrhosis
Autologous Bone Marrow Stem Cells Infusion Through Hepatic Artery in Open Abdominal Portal Hypertension Surgery for the Treatment of Liver Cirrhosis: a Prospective, Non-randomized, Controlled Study
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 18, 2012
CompletedFirst Posted
Study publicly available on registry
March 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMarch 22, 2012
March 1, 2012
3 years
March 18, 2012
March 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Child-pugh score
1 month after treament
Secondary Outcomes (6)
Incidence of complications
within the first week after treatment
Mortality
1week, 1 month, 3 month, 6 month, 1 year and 2 year
blood test (hypersplenism)
whinin 7 days before treatment, 1 week,1,3, 6 and 12 months after treatment
liver volume calculated by CT
whinin 7 days before treatment, 1 month and a year after treatment
Indocyanine green (ICG) retention (clearance)
whinin 7 days before treatment, 1 week,1,3, 6 and 12 months after treatment
- +1 more secondary outcomes
Study Arms (2)
ABMSCi plus surgery group
EXPERIMENTALAutologous bone marrow stem cells infusion through hepatic artery in open abdominal portal hypertension surgery
portal hypertension surgery group
NO INTERVENTIONonly portal hypertension surgery for this group patients
Interventions
Immediately 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
the modified Sugiura procedure was performed for the patients
Eligibility Criteria
You may qualify if:
- Advanced liver cirrhosis after hepatitis B resulted in bleeding from esophageal varices and hypersplenism, and needed open abdominal portal hypertension surgery;
- Endoscopy evidence of showing severe gastric and esophageal varices;
- Severe hypersplenism （white blood cells (WBC) \<3×109/L and platelet (PLT) \<100×109/L）;
- Active bone marrow hyperplasia showed by bone marrow biopsy before surgery;
- Age between 18 and 60 years;
- Plasma albumin \<35g/L, or mild ascites;
You may not qualify if:
- Enlisted for liver transplantation
- Diagnosis of hepatocellular carcinoma or other cancers
- Other severe medical disease, and acute infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000, China
Related Publications (4)
am Esch JS, Schmelzle M, Furst G, Robson SC, Krieg A, Duhme C, Tustas RY, Alexander A, Klein HM, Topp SA, Bode JG, Haussinger 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.
PMID: 22156926BACKGROUNDKim JK, Park YN, Kim JS, Park MS, Paik YH, Seok JY, Chung YE, Kim HO, Kim KS, Ahn SH, Kim DY, Kim MJ, Lee KS, Chon CY, Kim SJ, Terai S, Sakaida I, Han KH. Autologous bone marrow infusion activates the progenitor cell compartment in patients with advanced liver cirrhosis. Cell Transplant. 2010;19(10):1237-46. doi: 10.3727/096368910X506863. Epub 2010 Jun 3.
PMID: 20525430BACKGROUNDPeng L, Xie DY, Lin BL, Liu J, Zhu HP, Xie C, Zheng YB, Gao ZL. Autologous bone marrow mesenchymal stem cell transplantation in liver failure patients caused by hepatitis B: short-term and long-term outcomes. Hepatology. 2011 Sep 2;54(3):820-8. doi: 10.1002/hep.24434. Epub 2011 Jul 14.
PMID: 21608000BACKGROUNDTerai S, Ishikawa T, Omori K, Aoyama K, Marumoto Y, Urata Y, Yokoyama Y, Uchida K, Yamasaki T, Fujii Y, Okita K, Sakaida I. Improved liver function in patients with liver cirrhosis after autologous bone marrow cell infusion therapy. Stem Cells. 2006 Oct;24(10):2292-8. doi: 10.1634/stemcells.2005-0542. Epub 2006 Jun 15.
PMID: 16778155BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
qiyu zhang, MD
First Affiliated Hospital of Wenzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- the secretary-general of stem cell research center of Wenzhou Medical College
Study Record Dates
First Submitted
March 18, 2012
First Posted
March 22, 2012
Study Start
June 1, 2010
Primary Completion
June 1, 2013
Study Completion
June 1, 2014
Last Updated
March 22, 2012
Record last verified: 2012-03