Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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.

Tracking Information
First Submitted Date  ICMJE January 14, 2019
First Posted Date  ICMJE February 1, 2019
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03826433 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • 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
  • 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%
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 30, 2019)
  • 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.
  • Imaging examination [ Time Frame: 12 month ]
    After finish the mesenchymal stem cell treatment, observe the Computed Tomography (CT).
  • Imaging examination [ Time Frame: 12 month ]
    Fibro-Touch examination
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells(19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosis
Official Title  ICMJE Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosis
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis B
Intervention  ICMJE Biological: Peripheral iv
6*10^7 cells
Study Arms  ICMJE
  • 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)
    Intervention: Biological: Peripheral iv
  • No Intervention: Control Group
    Control Group: Using basic contrast .
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lei Guo, doctor 861064368977 georgeguo@sclnow.com
Contact: Xuegong Fan, doctor 86731-84327392 xgfan@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03826433
Other Study ID Numbers  ICMJE SCLnow-XY-04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sclnow Biotechnology Co., Ltd.
Study Sponsor  ICMJE Sclnow Biotechnology Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Xuegong Fan, doctor Xiangya Hospital of Central South University
PRS Account Sclnow Biotechnology Co., Ltd.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP