Liver Diseases
Conditions
Keywords
liver diseases, Bone Marrow Cell Transplantation
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREAutologous bone marrow stem cells infusion
Autologous bone marrow stem cells are infused into proper hepatic artery
DRUGdrugs such as Ursodeoxycholic Acid tablets
Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally
Sponsors
Wenzhou Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Definite liver diseases (such as viral hepatitis, autoimmune liver diseases, fatty liver diseases, ect); 2. Active bone marrow hyperplasia showed by bone marrow biopsy before ABMSCi; 3. Age between 18 and 60 years; 4. Abnormal liver function.
Exclusion criteria
1. Enlisted for liver transplantation 2. Diagnosis of hepatocellular carcinoma or other cancers 3. Other severe medical disease, and acute infection 4. pregnant or nursing females,co-infections with HIV ,serious bacterial infection 5. other vital organ or system dysfunction 6. with severe complications of liver cirrhosis 7. hematological disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline platelet at 6 months | baseline and 6 months after treatment | platelet (PLT) |
| Change from baseline total bilirubin at 6 months | baseline and 6 months after treatment | total bilirubin (TBil) |
| Change from baseline direct bilirubin at 6 months | baseline and 6 months after treatment | direct bilirubin (DBil) |
| Change from baseline total bile acid at 6 months | baseline and 6 months after treatment | total bile acid (TBA) |
| Change from baseline albumin at 6 months | baseline and 6 months after treatment | albumin (ALB) |
| Change from baseline prothrombin time at 6 months | baseline and 6 months after treatment | prothrombin time (PT), |
| Change from baseline international normalized ratio at 6 months | baseline and 6 months after treatment | international normalized ratio (INR) |
| Change from baseline white blood cell at 6 months | baseline and 6 months after treatment | white blood cell (WBC) |
| Change from baseline alanine aminotransferase at 6 months | baseline and 6 months after treatment | alanine aminotransferase (ALT) |
| Change from baseline aspartate aminotransferase at 6 months | baseline and 6 months after treatment | aspartate aminotransferase (AST) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline liver size at 6 months | baseline and 6 months after treatment | Enlarged size, normal size, shrunken size tested by abdominal B ultrasound/CT/MRI |
| Change from baseline spleen thickness at 6 months | baseline and 6 months after treatment | tested by abdominal B ultrasound/CT/MRI |
| Incidence of adverse events that are related to treatment | baseline and 6 months after treatment | Postoperative pyrexia, infection, liver cirrhosis, ascites, upper gastrointestinal hemorrhage, malignant tumors of liver and other organs |
| Number of participants that survive without developing disease | 12 months after treatment | — |
| Number of participants that survive with developing disease | 12 months after treatment | — |
| Number of participants that die after treatment | 12 months after treatment | — |
| Change from baseline liver density at 6 months | baseline and 6 months after treatment | Low density, medium density, high density tested by abdominal B ultrasound/CT/MRI |
Countries
China
Contacts
Primary Contactyongping chen
Backup Contactlanman xu
Outcome results
None listed