Autologous Bone Marrow Stem Cells Infusion for the Treatment of Liver Diseases. (ABMSCIFTLD)

Wenzhou Medical University

Status and phase: Unknown; Phase 2

Conditions: Liver Diseases

Treatments: Drug: drugs such as Ursodeoxycholic Acid tablets; Procedure: Autologous bone marrow stem cells infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT02943707

12330000470005914R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

treatment group: ABMSCi & drugs

Experimental group

Description:

ABMSCi: Autologous bone marrow stem cells infusion drugs such as Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally

Treatment:

Procedure: Autologous bone marrow stem cells infusion

Drug: drugs such as Ursodeoxycholic Acid tablets

control group: drugs

Active Comparator group

Description:

drugs such as Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally

Treatment:

Drug: drugs such as Ursodeoxycholic Acid tablets