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

October 21, 2016 updated by: yongping chen, Wenzhou Medical University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • yongping chen, MD
        • Principal Investigator:
          • lanman xu, PhD
        • Principal Investigator:
          • dazhi chen, MD
        • Principal Investigator:
          • minghua zheng, PhD
        • Principal Investigator:
          • keqing shi, MD
        • Principal Investigator:
          • yu huang, MD
        • Principal Investigator:
          • faling wu, MD
        • Principal Investigator:
          • ruicong chen, MD
        • Principal Investigator:
          • yunlei xiao, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group: ABMSCi & drugs
ABMSCi: Autologous bone marrow stem cells infusion drugs such as Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally
Procedure: Autologous bone marrow stem cells infusion
Autologous bone marrow stem cells are infused into proper hepatic artery
Other Names:
  • ABMSCi
Drug: drugs such as Ursodeoxycholic Acid tablets
Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally
Other Names:
  • UDCA
Active Comparator: control group: drugs
drugs such as Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally
Drug: drugs such as Ursodeoxycholic Acid tablets
Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally
Other Names:
  • UDCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline alanine aminotransferase at 6 months
Time Frame: baseline and 6 months after treatment
alanine aminotransferase (ALT)
baseline and 6 months after treatment
Change from baseline aspartate aminotransferase at 6 months
Time Frame: baseline and 6 months after treatment
aspartate aminotransferase (AST)
baseline and 6 months after treatment
Change from baseline total bilirubin at 6 months
Time Frame: baseline and 6 months after treatment
total bilirubin (TBil)
baseline and 6 months after treatment
Change from baseline direct bilirubin at 6 months
Time Frame: baseline and 6 months after treatment
direct bilirubin (DBil)
baseline and 6 months after treatment
Change from baseline total bile acid at 6 months
Time Frame: baseline and 6 months after treatment
total bile acid (TBA)
baseline and 6 months after treatment
Change from baseline albumin at 6 months
Time Frame: baseline and 6 months after treatment
albumin (ALB)
baseline and 6 months after treatment
Change from baseline prothrombin time at 6 months
Time Frame: baseline and 6 months after treatment
prothrombin time (PT),
baseline and 6 months after treatment
Change from baseline international normalized ratio at 6 months
Time Frame: baseline and 6 months after treatment
international normalized ratio (INR)
baseline and 6 months after treatment
Change from baseline white blood cell at 6 months
Time Frame: baseline and 6 months after treatment
white blood cell (WBC)
baseline and 6 months after treatment
Change from baseline platelet at 6 months
Time Frame: baseline and 6 months after treatment
platelet (PLT)
baseline and 6 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline liver density at 6 months
Time Frame: baseline and 6 months after treatment
Low density, medium density, high density tested by abdominal B ultrasound/CT/MRI
baseline and 6 months after treatment
Change from baseline liver size at 6 months
Time Frame: baseline and 6 months after treatment
Enlarged size, normal size, shrunken size tested by abdominal B ultrasound/CT/MRI
baseline and 6 months after treatment
Change from baseline spleen thickness at 6 months
Time Frame: baseline and 6 months after treatment
tested by abdominal B ultrasound/CT/MRI
baseline and 6 months after treatment
Incidence of adverse events that are related to treatment
Time Frame: baseline and 6 months after treatment
Postoperative pyrexia, infection, liver cirrhosis, ascites, upper gastrointestinal hemorrhage, malignant tumors of liver and other organs
baseline and 6 months after treatment
Number of participants that survive without developing disease
Time Frame: 12 months after treatment
12 months after treatment
Number of participants that survive with developing disease
Time Frame: 12 months after treatment
12 months after treatment
Number of participants that die after treatment
Time Frame: 12 months after treatment
12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenzhou Medical University

Investigators

  • Study Chair: yongping chen, First affiliated hospital of Wenzhou medical university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

October 17, 2016

First Submitted That Met QC Criteria

October 21, 2016

First Posted (Estimate)

October 25, 2016

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 21, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12330000470005914R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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