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

Primary Purpose

Hepatitis B

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Peripheral iv

About this trial

This is an interventional treatment trial for Hepatitis B focused on measuring Hepatitis B Cirrhosis, mesenchymal stem cell

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Xiangya Hospital Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

Control Group

Arm Description

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)

Control Group: Using basic contrast .

Outcomes

Primary Outcome Measures

Validity evaluation by detection of the Model for end-stage Liver Disease score of participants

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

Safety evaluation by detecting Blood routine

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

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%

Full Information

NCT ID

NCT03826433

First Posted

January 14, 2019

Last Updated

April 11, 2023

Sponsor

Sclnow Biotechnology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03826433

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sclnow Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Evaluation the safety of using human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis. Observe the curative effect of patients with hepatitis B cirrhosis who use human umbilical mesenchymal stem cells to treat. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B

Keywords

Hepatitis B Cirrhosis, mesenchymal stem cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Control Group: Using basic contrast .

Intervention Type

Biological

Intervention Name(s)

Peripheral iv

Intervention Description

6*10^7 cells

Primary Outcome Measure Information:

Title

Validity evaluation by detection of the Model for end-stage Liver Disease score of participants

Description

Time Frame

12 month

Secondary Outcome Measure Information:

Title

Safety evaluation by detecting Blood routine

Description

To calculate the number of hemocyte and related protein (e.g. erythrocyte, lymphocyte, and hemoglobin) after mesenchymal stem cell treatment

Time Frame

12 month

Title

Validity evaluation by detection of the child-pugh of participants

Description

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%

Time Frame

12 month

Other Pre-specified Outcome Measures:

Title

Validity evaluation by detection of the coagulation function of participants

Description

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.

Time Frame

12 month

Title

Imaging examination

Description

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

Time Frame

12 month

Title

Imaging examination

Description

Fibro-Touch examination

Time Frame

12 month

Title

Safety evaluation by detecting adverse events and serious adverse events

Description

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

Time Frame

12 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lei Guo, doctor

Phone

861064368977

georgeguo@sclnow.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xuegong Fan, doctor

Phone

86731-84327392

xgfan@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xuegong Fan, doctor

Organizational Affiliation

Xiangya Hospital of Central South University

Official's Role

Study Director

Facility Information:

Facility Name

Xiangya Hospital Central South University

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410008

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ShaLing Li, doctor

Phone

8613975186154

First Name & Middle Initial & Last Name & Degree

Xuegong Fan, doctor

Phone

86731-84327392

xgfan@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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