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| Name | Class |
|---|---|
| Zhejiang University | OTHER |
| Zhejiang General Hospital of Armed Police | OTHER |
| Zhenjiang First People's Hospital | OTHER |
| Wuhan General Hospital of Guangzhou Military Command |
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Orthotopic liver transplantation (OLT) is currently the most effective method for end-stage liver diseases. However, the critical shortage of donor organs, high cost, and the problem of immune rejection limit its clinical application, and even some patients on the waiting list will never survive to receive a matched liver. Stem cell transplantation instead of conventional medical therapy or orthotopic liver transplantation will be a promising alternate approach to regenerate damaged hepatic mass. Adult mesenchymal stem cells (MSCs) are generally thought of as an autologous source of regenerative cells in previous studies.In this study, the safety and efficacy of menstrual blood-derived stem cells transplantation for patients with liver cirrhosis will be evaluated.
The purpose of this study is to show whether menstrual blood-derived stem cells can improve the disease conditions in patients with liver cirrhosis.
One of two treatment arms will be assigned to the patients. One group will receive 2 weeks of conventional therapy plus MenSCs treatment; The other group will receive 2 weeks of conventional therapy plus placebo treatment.
MenSCs will be cultured and collected in a GMP lab. Patients were strictly monitored after the cells injection via i.v.. Patients are followed up at intervals up to at least 2 years.Clinical parameters such as ascites volume,serum alanine aminotransferase,total bilirubin,prothrombin time,albumin,MELD score,and Child-Pugh score will be evaluated at each timepoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Conventional therapy plus MenSCs treatment |
|
| No intervention | Active Comparator | Conventional therapy plus placebo treatment: Oral or intravenous administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional therapy plus MenSC transplantation | Biological | patients will receive conventional treatment,such as antiviral drugs, lowering aminotransferase and jaundice medicine. MenSCs transplantation: taken i.v., twice per week, at a dose of 1*10E6 MSC/kg body for 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function improvement | 48 weeks | |
| Complications | such as fever,anaphylaxis,cough,chest distress,and dyspnea,et al. | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charlie Xiang, Professor | S-Evans Biosciences Co., Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Zhejiang University-IRB | Hangzhou | Zhejiang | 310003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21987440 | Background | Houlihan DD, Hopkins LJ, Suresh SX, Armstrong MJ, Newsome PN. Autologous bone marrow mesenchymal stem cell transplantation in liver failure patients caused by hepatitis B: short-term and long-term outcomes. Hepatology. 2011 Nov;54(5):1891-2; author reply 1892. doi: 10.1002/hep.24722. No abstract available. | |
| 21608000 | Background |
| Label | URL |
|---|---|
| North American Indian childhood cirrhosis | View source |
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| OTHER |
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|
|
| Conventional therapy plus placebo treatment | Drug | 25 of the enrolled patients were assigned to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine. |
|
|
| The improvement of ascites after 12-week treatment |
| 48 weeks |
| Child-Pugh score | 48 weeks |
| MELD score | 48 weeks |
| SF36-quality of life | 48 weeks |
| Peng L, Xie DY, Lin BL, Liu J, Zhu HP, Xie C, Zheng YB, Gao ZL. Autologous bone marrow mesenchymal stem cell transplantation in liver failure patients caused by hepatitis B: short-term and long-term outcomes. Hepatology. 2011 Sep 2;54(3):820-8. doi: 10.1002/hep.24434. Epub 2011 Jul 14. |
| 21798218 | Background | Forbes SJ, Newsome PN. New horizons for stem cell therapy in liver disease. J Hepatol. 2012 Feb;56(2):496-9. doi: 10.1016/j.jhep.2011.06.022. Epub 2011 Jul 26. |
| 21194255 | Background | Nikeghbalian S, Pournasr B, Aghdami N, Rasekhi A, Geramizadeh B, Hosseini Asl SM, Ramzi M, Kakaei F, Namiri M, Malekzadeh R, Vosough Dizaj A, Malek-Hosseini SA, Baharvand H. Autologous transplantation of bone marrow-derived mononuclear and CD133(+) cells in patients with decompensated cirrhosis. Arch Iran Med. 2011 Jan;14(1):12-7. |
| 21326862 | Background | Zhang D, Jiang M, Miao D. Transplanted human amniotic membrane-derived mesenchymal stem cells ameliorate carbon tetrachloride-induced liver cirrhosis in mouse. PLoS One. 2011 Feb 4;6(2):e16789. doi: 10.1371/journal.pone.0016789. |
| Cirrhosis | View source |
| Related Info | View source |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007372 | Interferons |
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |
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