This study evaluates the effect of autologous bone marrow stem cells infusion (ABMSCi) therapy for liver diseases.Treatment group will receive ABMSCi and drugs therapy ,while control group will only receive drugs therapy.
1. Autologous bone marrow stem cells (ABMSC) mobilization and harvest For harvesting more ABMSC, ABMSC mobilization is induced by recombinant human granulocyte colony stimulating factor (rhGCSF,Gran○R), administered subcutaneously at a dose of 300μg daily for three consecutive days before bone marrow puncture. Bone marrow (160-200ml) of the patients is harvested from both posterior superior iliacs according to standard procedures under local anaesthesia and is collected in a plastic bag containing heparin. 2. Both treatment group and control group receive drugs therapy. 3. ABMSC separation and infusion ABMSC is separated and purified in a class 10,000 clean laboratory. After fat and bony particles are removed by filtration, collected cells are moved to a cell-processing device. 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 is measured by an automated complete blood count instrument and flow cytometry analysis. The number of mononuclear cells is counted manually under a microscope by Wright-Giemsa stain method. Cell differentiation factor 34(CD34) positive cells were determined by flow cytometry analysis. The time of ABMSC separation and purification is 2.5-3 hours. ABMSC is added to 10 ml saline and well mixed by shaking the vial gently. The catheter is 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 . The mixture of saline and ABMSC is infused into proper hepatic artery at uniform speed for about two minutes. The catheter is removed after the ABMSCi. 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 analysis is performed using the Statistic Package for Social Science (SPSS). All statistical analysis is based on two-tailed hypothesis tests with a significance level of p\< 0.05.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Autologous bone marrow stem cells are infused into proper hepatic artery
Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally
the First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
RECRUITINGChange from baseline alanine aminotransferase at 6 months
alanine aminotransferase (ALT)
Time frame: baseline and 6 months after treatment
Change from baseline aspartate aminotransferase at 6 months
aspartate aminotransferase (AST)
Time frame: baseline and 6 months after treatment
Change from baseline total bilirubin at 6 months
total bilirubin (TBil)
Time frame: baseline and 6 months after treatment
Change from baseline direct bilirubin at 6 months
direct bilirubin (DBil)
Time frame: baseline and 6 months after treatment
Change from baseline total bile acid at 6 months
total bile acid (TBA)
Time frame: baseline and 6 months after treatment
Change from baseline albumin at 6 months
albumin (ALB)
Time frame: baseline and 6 months after treatment
Change from baseline prothrombin time at 6 months
prothrombin time (PT),
Time frame: baseline and 6 months after treatment
Change from baseline international normalized ratio at 6 months
international normalized ratio (INR)
Time frame: baseline and 6 months after treatment
Change from baseline white blood cell at 6 months
white blood cell (WBC)
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Time frame: baseline and 6 months after treatment
Change from baseline platelet at 6 months
platelet (PLT)
Time frame: baseline and 6 months after treatment
Change from baseline liver density at 6 months
Low density, medium density, high density tested by abdominal B ultrasound/CT/MRI
Time frame: baseline and 6 months after treatment
Change from baseline liver size at 6 months
Enlarged size, normal size, shrunken size tested by abdominal B ultrasound/CT/MRI
Time frame: baseline and 6 months after treatment
Change from baseline spleen thickness at 6 months
tested by abdominal B ultrasound/CT/MRI
Time frame: baseline and 6 months after treatment
Incidence of adverse events that are related to treatment
Postoperative pyrexia, infection, liver cirrhosis, ascites, upper gastrointestinal hemorrhage, malignant tumors of liver and other organs
Time frame: baseline and 6 months after treatment
Number of participants that survive without developing disease
Time frame: 12 months after treatment
Number of participants that survive with developing disease
Time frame: 12 months after treatment
Number of participants that die after treatment
Time frame: 12 months after treatment