hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis

Sponsor
Sclnow Biotechnology Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03826433
Collaborator
(none)
20
1
2
56
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Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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 .

Outcome Measures

Primary Outcome Measures

  1. Validity evaluation by detection of the Model for end-stage Liver Disease score of participants [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 [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 [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 [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 [12 month]

    After finish the mesenchymal stem cell treatment, observe the Computed Tomography (CT).

  3. Imaging examination [12 month]

    Fibro-Touch examination

  4. Safety evaluation by detecting adverse events and serious adverse events [12 month]

    To evaluate the changes of safety indexes before and after mesenchymal stem cell treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xiangya Hospital Central South University Changsha Hunan China 410008

Sponsors and Collaborators

  • Sclnow Biotechnology Co., Ltd.

Investigators

  • Study Director: Xuegong Fan, doctor, Xiangya Hospital of Central South University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sclnow Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03826433
Other Study ID Numbers:
  • SCLnow-XY-04
First Posted:
Feb 1, 2019
Last Update Posted:
Jul 22, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2022