Safety and Efficacy of SHED for Decompensated Liver Cirrhosis
NCT ID: NCT03957655
Last Updated: 2019-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
40 participants
INTERVENTIONAL
2019-12-02
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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SHED group
SHED transplantation via peripheral vein: 1x10E6 SHEDs/kg body weight administered via peripheral vein at week 0,4,8,12.
SHED group
1x10E6 MSCs/kg body weight will be administered via peripheral vein for 4 times at week 0,4,8,12
Control
Standard medication for viral hepatitis and cirrhosis
No interventions assigned to this group
Interventions
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SHED group
1x10E6 MSCs/kg body weight will be administered via peripheral vein for 4 times at week 0,4,8,12
Eligibility Criteria
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Inclusion Criteria
2. HBV-related liver cirrhosis with presentations of decompensation
3. Antiviral treatment with nucleotide drugs for more than half a year and HBV DNA is less than the minimum detection limit;
4. Child-Pugh score B and MELD-Na score≤25
5. Written consent
Exclusion Criteria
2. Child-Pugh score A or C
3. Hepatocellular carcinoma or other malignancies
4. Cirrhosis or liver failure caused by non-Hepatitis B
5. Pregnancy or breastfeeding
6. Severe bacteria infection,coinfection with HIV or other viral hepatitis.
7. History of severe allergy to biological products or history of immunization within half a year
8. Patients or family members refused to participate in the study
9. Drug abuse or alcohol abuse
10. Other candidates who are judged to be not applicable to this study by doctors.
18 Years
70 Years
ALL
No
Sponsors
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Eastern Hepatobiliary Surgery Hospital
OTHER
CAR-T (Shanghai) Biotechnology Co., Ltd.
INDUSTRY
Changhai Hospital
OTHER
Responsible Party
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Zhaoshen Li
Prof.
Principal Investigators
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Zhaoshen Li, Dr.
Role: STUDY_CHAIR
Changhai Hospital
Chengzhong Li, Dr.
Role: STUDY_DIRECTOR
Changhai Hospital
Lei Xin, Dr.
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Jianya Xue, Dr.
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Locations
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Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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SHED01
Identifier Type: -
Identifier Source: org_study_id
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