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| Name | Class |
|---|---|
| Eastern Hepatobiliary Surgery Hospital | OTHER |
| CAR-T (Shanghai) Biotechnology Co., Ltd. | INDUSTRY |
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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). The primary outcome is MELD-Na score. Secondary outcomes are Child-Pugh, liver function, life quality and survival.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHED group | Experimental | SHED transplantation via peripheral vein: 1x10E6 SHEDs/kg body weight administered via peripheral vein at week 0,4,8,12. |
|
| Control | No Intervention | Standard medication for viral hepatitis and cirrhosis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHED group | Biological | 1x10E6 MSCs/kg body weight will be administered via peripheral vein for 4 times at week 0,4,8,12 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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)](streamdown:incomplete-link) | baseline and 4,8,12,16,24 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Xin, Dr. | Contact | 862131161365 | aip_xin@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhaoshen Li, Dr. | Changhai Hospital | Study Chair |
| Chengzhong Li, Dr. | Changhai Hospital | Study Director |
| Lei Xin, Dr. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29478901 | Background | 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. | |
| 30135248 |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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Outcome assessors will be blind to the randomization results of the participants.
| baseline and 4,8,12,16,24 week |
| Changes of liver function | Changes of liver function index such as ALT, AST, ALB, TBIL, PT | baseline and 4,8,12,16,24 week |
| Changes of life quality | Changes of life quality as assessed by SF-36 | baseline and 4,8,12,16,24 week |
| Survival Rate at half of one year | Survival rate at half of one year | half of one year |
| Changhai Hospital |
| Principal Investigator |
| Jianya Xue, Dr. | Changhai Hospital | Principal Investigator |
| 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. |
| 28217369 | Background | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |