Autologous Bone Marrow Stem Cells Infusion for the Treatment of Liver Diseases.
- Conditions
- Liver Diseases
- Interventions
- Procedure: Autologous bone marrow stem cells infusionDrug: drugs such as Ursodeoxycholic Acid tablets
- Registration Number
- NCT02943707
- Lead Sponsor
- Wenzhou Medical University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- Definite liver diseases (such as viral hepatitis, autoimmune liver diseases, fatty liver diseases, ect);
- Active bone marrow hyperplasia showed by bone marrow biopsy before ABMSCi;
- Age between 18 and 60 years;
- Abnormal liver function.
- Enlisted for liver transplantation
- Diagnosis of hepatocellular carcinoma or other cancers
- Other severe medical disease, and acute infection
- pregnant or nursing females,co-infections with HIV ,serious bacterial infection
- other vital organ or system dysfunction
- with severe complications of liver cirrhosis
- hematological disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description treatment group: ABMSCi & drugs drugs such as Ursodeoxycholic Acid tablets ABMSCi: Autologous bone marrow stem cells infusion drugs such as Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally control group: drugs drugs such as Ursodeoxycholic Acid tablets drugs such as Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally treatment group: ABMSCi & drugs Autologous bone marrow stem cells infusion ABMSCi: Autologous bone marrow stem cells infusion drugs such as Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally
- Primary Outcome Measures
Name Time Method Change from baseline alanine aminotransferase at 6 months baseline and 6 months after treatment alanine aminotransferase (ALT)
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 aspartate aminotransferase at 6 months baseline and 6 months after treatment aspartate aminotransferase (AST)
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 platelet at 6 months baseline and 6 months after treatment platelet (PLT)
- Secondary Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
the First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China