Clinical trial NCT01483248: Human Menstrual Blood-derived Mesenchymal Stem Cells for Patients With Liver Cirrhosis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Liver Cirrhosis
Fibrosis
Liver Disease
Digestive System Disease
Keywords: Menstrual blood
Mesenchymal stem cell
Liver cirrhosis
Lead sponsor: S-Evans Biosciences Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Zhejiang University
name: Zhejiang General Hospital of Armed Police
name: Zhenjiang First People's Hospital
name: Wuhan General Hospital of Guangzhou Military Command
First posted: 2011-12-01
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: 48 weeks
Secondary outcomes:
measure: Liver function improvement
timeFrame: 48 weeks
measure: Complications
timeFrame: 48 weeks
measure: The improvement of ascites after 12-week treatment
timeFrame: 48 weeks
measure: Child-Pugh score
timeFrame: 48 weeks
measure: MELD score
timeFrame: 48 weeks
measure: SF36-quality of life
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the First Affiliated Hospital of Zhejiang University-IRB
state: Zhejiang
Study officials:
affiliation: S-Evans Biosciences Co., Ltd.
name: Charlie Xiang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
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.
citation: 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.
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.
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.