Back to resultsSafety and Efficacy of SHED for Decompensated Liver Cirrhosis
Primary Purpose
Liver Cirrhosis
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
SHED group
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis focused on measuring Liver Cirrhosis, stem cell, therapy
Eligibility Criteria
Inclusion Criteria:
- Aged 18-70 years
- HBV-related liver cirrhosis with presentations of decompensation
- Antiviral treatment with nucleotide drugs for more than half a year and HBV DNA is less than the minimum detection limit;
- Child-Pugh score B and MELD-Na score≤25
- Written consent
Exclusion Criteria:
- Hepatic encephalopathy, hepatorenal syndrome, acute phase of severe hepatitis
- Child-Pugh score A or C
- Hepatocellular carcinoma or other malignancies
- Cirrhosis or liver failure caused by non-Hepatitis B
- Pregnancy or breastfeeding
- Severe bacteria infection,coinfection with HIV or other viral hepatitis.
- History of severe allergy to biological products or history of immunization within half a year
- Patients or family members refused to participate in the study
- Drug abuse or alcohol abuse
- Other candidates who are judged to be not applicable to this study by doctors.
Sites / Locations
- Changhai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SHED group
Control
Arm Description
SHED transplantation via peripheral vein: 1x10E6 SHEDs/kg body weight administered via peripheral vein at week 0,4,8,12.
Standard medication for viral hepatitis and cirrhosis
Outcomes
Primary Outcome Measures
Model for End-Stage Liver Disease (MELD)-Na score
The MELD-Na score is a reliable measure of mortality risk in patients with end-stage liver disease.
MELD-Na score=3.8ln[bilirubin (mg/dl)]+11.21ln(INR) +9.6ln[creatinine (mg/dl) +6.4* (cause: cholestasis and alcoholic cirrhosis are 0, others are 1) +1.59* (135-Na)
Secondary Outcome Measures
Child-Pugh score
The Child-Pugh score is a scoring system to measure the severity of chronic liver disease inclusive of cirrhosis. The point scores are added up and classified as: class A: 5-6 points class B: 7-9 points class C: 10-15 points
The score is composed from several categories:
total bilirubin, μmol/l (mg/dl)<34: 1 point 34-50: 2 points >50: 3 points
serum albumin, g/l>35: 1 point 28-35: 2 points <28: 3 points
INR<1.7: 1 point 1.7-2.3: 2 points >2.3: 3 points
presence of ascites none: 1 point mild: 2 points moderate to severe: 3 points
presence of hepatic encephalopathy none: 1 point grades I-II : 2 point grades III-IV: 3 point
Changes of liver function
Changes of liver function index such as ALT, AST, ALB, TBIL, PT
Changes of life quality
Changes of life quality as assessed by SF-36
Survival Rate at half of one year
Survival rate at half of one year
Full Information
NCT ID
NCT03957655
First Posted
May 19, 2019
Last Updated
December 1, 2019
Sponsor
Changhai Hospital
Collaborators
Eastern Hepatobiliary Surgery Hospital, CAR-T (Shanghai) Biotechnology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03957655
Brief Title
Safety and Efficacy of SHED for Decompensated Liver Cirrhosis
Official Title
Safety and Efficacy of Stem Cells From Human Exfoliated Deciduous Teeth for Treatment of Decompensated Liver Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2, 2019 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
Collaborators
Eastern Hepatobiliary Surgery Hospital, CAR-T (Shanghai) Biotechnology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is an prospective, randomized control study. Patients with decompensated cirrhosis will be randomly assigned to receive 4 times of SHED treatment plus standard medical care(treatment）or standard medical care (control). The primary outcome is MELD-Na score. Secondary outcomes are Child-Pugh, liver function, life quality and survival.
Detailed Description
At present, there is still no effective treatment for liver cirrhosis, and the use of stem cells for the treatment of cirrhosis has caused great concern.Stem cells from human exfoliated deciduous teeth (SHED) has been shown to be safe and effective for liver diseases. Randomization controlled studies are needed to confirm the long term effect of SHED treatment for liver cirrhosis. The present study aimed to investigate the safety and efficacy of SHED in hepatitis B related liver cirrhosis patients.
This study is an prospective, randomized control study. Patients with decompensated cirrhosis will be randomly assigned to receive 4 times of SHED treatment plus standard medical care(treatment）or standard medical care (control). SHED infusion (1x10E6 cells/kg body weight) via peripheral vein will be given at week 0,4,8,12.The primary outcome is MELD-Na score. Secondary outcomes are Child-Pugh, liver function, life quality and survival.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
Liver Cirrhosis, stem cell, therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be blind to the randomization results of the participants.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHED group
Arm Type
Experimental
Arm Description
SHED transplantation via peripheral vein: 1x10E6 SHEDs/kg body weight administered via peripheral vein at week 0,4,8,12.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard medication for viral hepatitis and cirrhosis
Intervention Type
Biological
Intervention Name(s)
SHED group
Intervention Description
1x10E6 MSCs/kg body weight will be administered via peripheral vein for 4 times at week 0,4,8,12
Primary Outcome Measure Information:
Title
Model for End-Stage Liver Disease (MELD)-Na score
Description
The MELD-Na score is a reliable measure of mortality risk in patients with end-stage liver disease.
MELD-Na score=3.8ln[bilirubin (mg/dl)]+11.21ln(INR) +9.6ln[creatinine (mg/dl) +6.4* (cause: cholestasis and alcoholic cirrhosis are 0, others are 1) +1.59* (135-Na)
Time Frame
baseline and 4,8,12,16,24 week
Secondary Outcome Measure Information:
Title
Child-Pugh score
Description
The Child-Pugh score is a scoring system to measure the severity of chronic liver disease inclusive of cirrhosis. The point scores are added up and classified as: class A: 5-6 points class B: 7-9 points class C: 10-15 points
The score is composed from several categories:
total bilirubin, μmol/l (mg/dl)<34: 1 point 34-50: 2 points >50: 3 points
serum albumin, g/l>35: 1 point 28-35: 2 points <28: 3 points
INR<1.7: 1 point 1.7-2.3: 2 points >2.3: 3 points
presence of ascites none: 1 point mild: 2 points moderate to severe: 3 points
presence of hepatic encephalopathy none: 1 point grades I-II : 2 point grades III-IV: 3 point
Time Frame
baseline and 4,8,12,16,24 week
Title
Changes of liver function
Description
Changes of liver function index such as ALT, AST, ALB, TBIL, PT
Time Frame
baseline and 4,8,12,16,24 week
Title
Changes of life quality
Description
Changes of life quality as assessed by SF-36
Time Frame
baseline and 4,8,12,16,24 week
Title
Survival Rate at half of one year
Description
Survival rate at half of one year
Time Frame
half of one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18-70 years
HBV-related liver cirrhosis with presentations of decompensation
Antiviral treatment with nucleotide drugs for more than half a year and HBV DNA is less than the minimum detection limit;
Child-Pugh score B and MELD-Na score≤25
Written consent
Exclusion Criteria:
Hepatic encephalopathy, hepatorenal syndrome, acute phase of severe hepatitis
Child-Pugh score A or C
Hepatocellular carcinoma or other malignancies
Cirrhosis or liver failure caused by non-Hepatitis B
Pregnancy or breastfeeding
Severe bacteria infection,coinfection with HIV or other viral hepatitis.
History of severe allergy to biological products or history of immunization within half a year
Patients or family members refused to participate in the study
Drug abuse or alcohol abuse
Other candidates who are judged to be not applicable to this study by doctors.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Xin, Dr.
Phone
862131161365
Email
aip_xin@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoshen Li, Dr.
Organizational Affiliation
Changhai Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chengzhong Li, Dr.
Organizational Affiliation
Changhai Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lei Xin, Dr.
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianya Xue, Dr.
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Xin, Dr.
Phone
862131161365
Email
aip_xin@163.com
First Name & Middle Initial & Last Name & Degree
Jianya Xue, Dr.
First Name & Middle Initial & Last Name & Degree
Lei Xin, Dr.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29478901
Citation
Wang D, Zhang H, Liang J, Wang H, Hua B, Feng X, Gilkeson GS, Farge D, Shi S, Sun L. A Long-Term Follow-Up Study of Allogeneic Mesenchymal Stem/Stromal Cell Transplantation in Patients with Drug-Resistant Systemic Lupus Erythematosus. Stem Cell Reports. 2018 Mar 13;10(3):933-941. doi: 10.1016/j.stemcr.2018.01.029. Epub 2018 Mar 1.
Results Reference
background
PubMed Identifier
30135248
Citation
Xuan K, Li B, Guo H, Sun W, Kou X, He X, Zhang Y, Sun J, Liu A, Liao L, Liu S, Liu W, Hu C, Shi S, Jin Y. Deciduous autologous tooth stem cells regenerate dental pulp after implantation into injured teeth. Sci Transl Med. 2018 Aug 22;10(455):eaaf3227. doi: 10.1126/scitranslmed.aaf3227.
Results Reference
background
PubMed Identifier
28217369
Citation
Ohkoshi S, Hara H, Hirono H, Watanabe K, Hasegawa K. Regenerative medicine using dental pulp stem cells for liver diseases. World J Gastrointest Pharmacol Ther. 2017 Feb 6;8(1):1-6. doi: 10.4292/wjgpt.v8.i1.1.
Results Reference
background
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Safety and Efficacy of SHED for Decompensated Liver Cirrhosis
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