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

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ClinicalTrials.gov Identifier: NCT02943707
Recruitment Status : Recruiting
First Posted : October 25, 2016
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
yongping chen, 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.

Condition or disease Intervention/treatment Phase
Liver Diseases Procedure: Autologous bone marrow stem cells infusion Drug: drugs such as Ursodeoxycholic Acid tablets Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Stem Cells Infusion for the Treatment of Liver Diseases.
Study Start Date : October 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases
Drug Information available for: Ursodiol

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 Name: ABMSCi

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




Primary Outcome Measures :
  1. Change from baseline alanine aminotransferase at 6 months [ Time Frame: baseline and 6 months after treatment ]
    alanine aminotransferase (ALT)

  2. Change from baseline aspartate aminotransferase at 6 months [ Time Frame: baseline and 6 months after treatment ]
    aspartate aminotransferase (AST)

  3. Change from baseline total bilirubin at 6 months [ Time Frame: baseline and 6 months after treatment ]
    total bilirubin (TBil)

  4. Change from baseline direct bilirubin at 6 months [ Time Frame: baseline and 6 months after treatment ]
    direct bilirubin (DBil)

  5. Change from baseline total bile acid at 6 months [ Time Frame: baseline and 6 months after treatment ]
    total bile acid (TBA)

  6. Change from baseline albumin at 6 months [ Time Frame: baseline and 6 months after treatment ]
    albumin (ALB)

  7. Change from baseline prothrombin time at 6 months [ Time Frame: baseline and 6 months after treatment ]
    prothrombin time (PT),

  8. Change from baseline international normalized ratio at 6 months [ Time Frame: baseline and 6 months after treatment ]
    international normalized ratio (INR)

  9. Change from baseline white blood cell at 6 months [ Time Frame: baseline and 6 months after treatment ]
    white blood cell (WBC)

  10. Change from baseline platelet at 6 months [ Time Frame: baseline and 6 months after treatment ]
    platelet (PLT)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Change from baseline spleen thickness at 6 months [ Time Frame: baseline and 6 months after treatment ]
    tested by abdominal B ultrasound/CT/MRI

  4. 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

  5. Number of participants that survive without developing disease [ Time Frame: 12 months after treatment ]
  6. Number of participants that survive with developing disease [ Time Frame: 12 months after treatment ]
  7. Number of participants that die after treatment [ Time Frame: 12 months after treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943707


Contacts
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Contact: yongping chen 8613505777281 13505777281@163.com
Contact: lanman xu 8613587646315 13587646315@163.com

Locations
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China, Zhejiang
the First Affiliated Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: yongping chen    8613505777281    13505777281@163.com   
Contact: lanman xu    8613587646315    13587646315@163.com   
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         
Sponsors and Collaborators
Wenzhou Medical University
Investigators
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Study Chair: yongping chen First Affiliated Hospital of Wenzhou Medical University

Publications of Results:

Other Publications:
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Responsible Party: yongping chen, Director,Clinical Research, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT02943707     History of Changes
Other Study ID Numbers: 12330000470005914R
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by yongping chen, Wenzhou Medical University:
liver diseases
Bone Marrow Cell Transplantation

Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents