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Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells(19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosis

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ClinicalTrials.gov Identifier: NCT03826433
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Sclnow Biotechnology Co., Ltd.

Brief Summary:
  1. Evaluation the safety of using human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis.
  2. Observe the curative effect of patients with hepatitis B cirrhosis who use human umbilical mesenchymal stem cells to treat.
  3. Explore the possible mechanism of human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: Peripheral iv Phase 1

Detailed Description:

This experimental use umbilical cord mesenchymal stem cells in treatment of decompensated hepatitis B cirrhosis to evaluate its safety and efficacy,

This experimental is mainly aimed at people aged 18-60 years old, regardless of gender and with body mass index (BMI) between 19-25kg/m2 (including boundary value). It was decided into treatment group and control group to evaluate the effectiveness and safety of mesenchymal stem cells by peripheral intravenous injection.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosis
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group
Mesenchymal Stem Cells : through peripheral intravenous slowly, every time 6*10^7 (30ml) Other medication of Treatment Group: before the30min of first time to inject stem cells, Intravenous methylprednisone 20mg. All patients require oral nucleoside drugs resistant hepatitis B virus treatment.Use stem cell therapy, by Peripheral iv, 6 * 10 ^ 7 (30 ml)
Biological: Peripheral iv
6*10^7 cells

No Intervention: Control Group
Control Group: Using basic contrast .



Primary Outcome Measures :
  1. Validity evaluation by detection of the Model for end-stage Liver Disease score of participants [ Time Frame: 12 month ]

    After finish the mesenchymal stem cell treatment, observe the change in baseline outcome measures.

    40 or more — 71.3% observed mortality 30-39 — 52.6% observed mortality 20-29 — 19.6% observed mortality 10-19 — 6.0% observed mortality <9 — 1.9% observed mortality



Secondary Outcome Measures :
  1. Safety evaluation by detecting Blood routine [ Time Frame: 12 month ]
    To calculate the number of hemocyte and related protein (e.g. erythrocyte, lymphocyte, and hemoglobin) after mesenchymal stem cell treatment

  2. Validity evaluation by detection of the child-pugh of participants [ Time Frame: 12 month ]

    After finish the mesenchymal stem cell treatment, observe the change in baseline outcome measures.

    Points Class One-year survival Two-year survival 5-6 A 100% 85% 7-9 B 80% 60% 10-15 C 45% 35%



Other Outcome Measures:
  1. Validity evaluation by detection of the coagulation function of participants [ Time Frame: 12 month ]

    After finish the mesenchymal stem cell treatment, observe the change of Prothrombin Time and International Normalized Ratio (PT/INR) in baseline outcome measures.

    The time is around 12-13 seconds, the INR in absence of anticoagulation therapy is 0.8-1.2.


  2. Imaging examination [ Time Frame: 12 month ]
    After finish the mesenchymal stem cell treatment, observe the Computed Tomography (CT).

  3. Imaging examination [ Time Frame: 12 month ]
    Fibro-Touch examination

  4. Safety evaluation by detecting adverse events and serious adverse events [ Time Frame: 12 month ]
    To evaluate the changes of safety indexes before and after mesenchymal stem cell 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:

  • Age 18-60 years old, gender not limited, body mass index (BMI) between 19-25 kg/m2, including boundary value;
  • The diagnosis of hepatitis B cirrhosis was in line with the 2015 American society of hepatology (AASLD) guidelines for the treatment of chronic hepatitis B, and the liver function grade was child-pugh B or child-pugh C, with a score range of 7-12 points, and Model for End-Stage Liver Disease score≤21 points.
  • Have not received stem cell therapy in the recent 6 months;
  • Subjects will be able to sign the informed consent in accordance with the study procedures and instructions.

Exclusion Criteria:

  • Insufficiency of vital organs, such as heart, kidney and lung;
  • End-stage cirrhosis with severe complications, including but not limited to: hepatic encephalopathy, gastrointestinal bleeding,Severe bleeding tendency, massive ascites, etc.
  • Concomitant peritonitis, pneumonia, or other types of infection not under control;
  • Have a history of severe allergic reaction or allergy to two or more kinds of food or medicine;
  • Positive serum HIV antibody and syphilis antibody;
  • Alpha fetoprotein>400ng/mL with primary liver cancer or without imaging evidence;
  • Chronic liver disease and cirrhosis are caused by non-chronic hepatitis B virus infection, or other factors except chronic hepatitis B virus infection ;
  • Patients with severe mental illness and cognitive impairment;

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): NCT03826433


Contacts
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Contact: Lei Guo, doctor 861064368977 georgeguo@sclnow.com
Contact: Xuegong Fan, doctor 86731-84327392 xgfan@hotmail.com

Locations
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China, Hunan
Xiangya Hospital Central South University Recruiting
Changsha, Hunan, China, 410008
Contact: ShaLing Li, doctor    8613975186154      
Contact: Xuegong Fan, doctor    86731-84327392    xgfan@hotmail.com   
Sponsors and Collaborators
Sclnow Biotechnology Co., Ltd.
Investigators
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Study Director: Xuegong Fan, doctor Xiangya Hospital of Central South University

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Responsible Party: Sclnow Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03826433     History of Changes
Other Study ID Numbers: SCLnow-XY-04
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sclnow Biotechnology Co., Ltd.:
Hepatitis B Cirrhosis, mesenchymal stem cell

Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Pathologic Processes
Hepatitis
Hepatitis A
Hepatitis B
Fibrosis
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections