ABMSC Infusion Through Hepatic Artery in Portal Hypertension Surgery for the Treatment of Liver Cirrhosis
|ClinicalTrials.gov Identifier: NCT01560845|
Recruitment Status : Unknown
Verified March 2012 by Qiqiang Zeng, Wenzhou Medical College.
Recruitment status was: Recruiting
First Posted : March 22, 2012
Last Update Posted : March 22, 2012
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis Portal Hypertension Hepatic Decompensation Surgery||Procedure: Autologous bone marrow stem cells infusion （ABMSCi） plus abdominal portal hypertension surgery Procedure: open abdominal portal hypertension surgery||Phase 2 Phase 3|
ABMSC mobilization and harvest
- For harvesting more ABMSC, ABMSC mobilization was induced by rhG-CSF (Gran○R), administered subcutaneously at a dose of 300μg daily for three consecutive days before open abdominal portal hypertension surgery.
- Bone marrow (160-200ml) of the patients was harvested from both posterior superior iliac according to standard procedures under local anaesthesia and was collected in a plastic bag containing heparin.
Open abdominal portal hypertension surgery
- Immediately after the harvest of ABMSC, the modified Sugiura procedure was performed for the patients who were assigned to the study group. The same surgical procedure was also performed for the control group (without harvest of ABMSC and ABMSC infusion).
ABMSC separation and infusion
- While performing the portal hypertension surgery, ABMSC was separated and purified in a class 10,000 clean laboratory. After fat and bony particles were removed by filtration, collected cells were moved to a cell-processing device. We used the reagent kit ([Patent Number] ZL 2006 1 0106875.5; [Number of Criteria Applicable] YZB/NING YIN 0008-2008; [Researcher and Developer] Wealthlin Science & Technology Inc., Canada; [Producer] Ningxia Zhonglianda Biotech Co., Ltd.). The reagents adopt the method of negative cells collection. Take the cells which intended to remove as target cells, and carry out the removal step-by-step. On the basis of this method, red blood cells, blood platelets, blood plasma will be completely removed with part of white cells and lymphocytes being remarkably removed as well while all the stem cells / progenitor cells are being well retained.
- The nucleated cell (white blood cell) count of final ABMSC was measured by an automated complete blood count instrument and flow cytometry analysis. The number of mononuclear cells was counted manually under a microscope by Wright-Giemsa stain method. CD34 positive cells were determined by flow cytometry analysis.
- 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 added to 10 ml saline and well mixed by shaking the vial gently. Before incision closure, the right gastric artery or right gastroepiploic artery was selected and a catheter was inserted. The catheter was pushed to reach the proper hepatic artery. The diameter of the catheter is 1.4mm, it is thin enough to easily been inserted to right gastric artery or right gastroepiploic artery (central venous catheterization, REF product NO.ES-04218, Arrow International, Inc.). The mixture of saline and AMBC was infused into hepatic artery at uniform speed for about two minutes. The catheter was removed after the ABMSCi. The puncture point of the right gastric artery was repaired using blood vessel suture or transfixed.
- Statistical analysis - Categorical data are presented as absolute values and percentages, whereas continuous data are summarized as mean and Standard Deviation. Statistical analysis was performed using t-test for paired or unpaired samples. Time courses of measurements of liver function parameters were analyzed by repeated-measures ANOVA. The analyses were performed using the SPSS 15.0 statistical package (SPSS Inc., Chicago, IL, USA). All statistical analyses were based on two-tailed hypothesis tests with a significance level of p< 0.05.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||June 2014|
Experimental: ABMSCi plus surgery group
Autologous bone marrow stem cells infusion through hepatic artery in open abdominal portal hypertension surgery
Procedure: Autologous bone marrow stem cells infusion （ABMSCi） plus abdominal portal hypertension surgery
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
No Intervention: portal hypertension surgery group
only portal hypertension surgery for this group patients
Procedure: open abdominal portal hypertension surgery
the modified Sugiura procedure was performed for the patients
- Child-pugh score [ Time Frame: 1 month after treament ]
- Incidence of complications [ Time Frame: within the first week after treatment ]postoperative pyrexia, intraperitoneal hemorrhage, intraperitoneal infection, malignant tumors of liver and other systems
- Mortality [ Time Frame: 1week, 1 month, 3 month, 6 month, 1 year and 2 year ]
- blood test (hypersplenism) [ Time Frame: whinin 7 days before treatment, 1 week,1,3, 6 and 12 months after treatment ]PLT and WBC
- liver volume calculated by CT [ Time Frame: whinin 7 days before treatment, 1 month and a year after treatment ]estimation of liver volume using CT
- Indocyanine green (ICG) retention (clearance) [ Time Frame: whinin 7 days before treatment, 1 week,1,3, 6 and 12 months after treatment ]
- blood biochemistry [ Time Frame: whinin 7 days before treatment, 1 week,1,3, 6 and 12 months after treatment ]
- alanine aminotransferase
- aspartate aminotransferase
- total bilirubin
- direct bilirubin
- The total bile acid (TBA)
- serum cholinesterase (CHE)
- prothrombin time (PT)
- international normalized ratio (INR)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560845
|Contact: qiqiang zeng, MDfirstname.lastname@example.org|
|the First Affiliated Hospital of Wenzhou Medical College||Recruiting|
|Wenzhou, Zhejiang, China, 325000|
|Contact: qiqiang zeng, MD 86-0577-88069307 email@example.com|
|Principal Investigator: qiqiang zeng, MD|
|Principal Investigator: yi liao, MD|
|Principal Investigator: minghua zheng, MD|
|Principal Investigator: bing liang, MD|
|Principal Investigator: zhiming li, MD|
|Principal Investigator: qigang xu, MD|
|Principal Investigator: yi wang, MD|
|Principal Investigator: zhengping yu, MD|
|Principal Investigator: hongqi shi, MD|
|Study Chair:||qiyu zhang, MD||First Affiliated Hospital of Wenzhou Medical Univeristy|