Liver Cirrhosis Clinical Trial
Official title:
Phase 1/2 Study of Human Menstrual Blood-derived Mesenchymal Stem Cells Transplantation for the Evaluation of the Efficacy and Safety in Patients With Liver Cirrhosis
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.
Status | Enrolling by invitation |
Enrollment | 50 |
Est. completion date | October 2015 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Written informed consent - Aged 20 to 50years - Liver cirrhosis - Negative pregnancy test Exclusion Criteria: - Pregnant or lactating women - Malignancies - Sepsis - Vital organs failure - Severe bacteria infection - Vascular thromboses in the portal or hepatic veins |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | the First Affiliated Hospital of Zhejiang University-IRB | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
S-Evans Biosciences Co.,Ltd. | First Affiliated Hospital of Zhejiang University, Wuhan General Hospital of Guangzhou Military Command, Zhejiang General Hospital of Armed Police, Zhejiang University |
China,
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. Review. — View Citation
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. — View Citation
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. doi: 011141/AIM.004. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | 48 weeks | No | |
Secondary | Liver function improvement | 48 weeks | No | |
Secondary | Complications | such as fever,anaphylaxis,cough,chest distress,and dyspnea,et al. | 48 weeks | No |
Secondary | The improvement of ascites after 12-week treatment | 48 weeks | No | |
Secondary | Child-Pugh score | 48 weeks | No | |
Secondary | MELD score | 48 weeks | No | |
Secondary | SF36-quality of life | 48 weeks | No |
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