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ABMSC Infusion Through Hepatic Artery in Portal Hypertension Surgery for the Treatment of Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT01560845
Recruitment Status : Unknown
Verified March 2012 by Qiqiang Zeng, Wenzhou Medical University.
Recruitment status was:  Recruiting
First Posted : March 22, 2012
Last Update Posted : March 22, 2012
Sponsor:
Information provided by (Responsible Party):
Qiqiang Zeng, Wenzhou Medical University

March 18, 2012
March 22, 2012
March 22, 2012
June 2010
June 2013   (Final data collection date for primary outcome measure)
Child-pugh score [ Time Frame: 1 month after treament ]
Same as current
No Changes Posted
  • 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 ]
    1. alanine aminotransferase
    2. aspartate aminotransferase
    3. total bilirubin
    4. direct bilirubin
    5. The total bile acid (TBA)
    6. serum cholinesterase (CHE)
    7. albumin
    8. prothrombin time (PT)
    9. international normalized ratio (INR)
Same as current
Not Provided
Not Provided
 
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
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.
  1. 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.
  2. 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).

  3. 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.
  4. 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.
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Liver Cirrhosis
  • Portal Hypertension
  • Hepatic Decompensation
  • 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
  • Procedure: open abdominal portal hypertension surgery
    the modified Sugiura procedure was performed for the patients
  • Experimental: ABMSCi plus surgery group
    Autologous bone marrow stem cells infusion through hepatic artery in open abdominal portal hypertension surgery
    Intervention: Procedure: Autologous bone marrow stem cells infusion (ABMSCi) plus abdominal portal hypertension surgery
  • No Intervention: portal hypertension surgery group
    only portal hypertension surgery for this group patients
    Intervention: Procedure: open abdominal portal hypertension surgery

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
Same as current
June 2014
June 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01560845
WZMC1-10-1
No
Not Provided
Not Provided
Qiqiang Zeng, Wenzhou Medical University
Wenzhou Medical University
Not Provided
Study Chair: qiyu zhang, MD First Affiliated Hospital of Wenzhou Medical University
Wenzhou Medical University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP