Human Menstrual Blood-derived Mesenchymal Stem Cells for Patients With Liver Cirrhosis

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Liver Cirrhosis; Fibrosis; Liver Disease; Digestive System Disease	Biological: conventional therapy plus MenSC transplantation; Drug: Conventional therapy plus placebo treatment	Phase 1; Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	October 2010
Estimated Primary Completion Date :	October 2013
Estimated Study Completion Date :	October 2015

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Intervention; Conventional therapy plus MenSCs treatment	Biological: conventional therapy plus MenSC transplantation; 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.; Other Names: Interferon; Bifendatatum; Ursodeoxycholic Acid; Menstrual blood-derived stem cells(MenSCs)
Active Comparator: No intervention; Conventional therapy plus placebo treatment: Oral or intravenous administration	Drug: Conventional therapy plus placebo treatment; 25 of the enrolled patients were assigned to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.; Other Names: Interferon; Bifendatatum; Ursodeoxycholic Acid

Outcome Measures

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Primary Outcome Measures :

1. Overall Survival [ Time Frame: 48 weeks ]

Secondary Outcome Measures :

1. Liver function improvement [ Time Frame: 48 weeks ]
2. Complications [ Time Frame: 48 weeks ]
   such as fever,anaphylaxis,cough,chest distress,and dyspnea,et al.
3. The improvement of ascites after 12-week treatment [ Time Frame: 48 weeks ]
4. Child-Pugh score [ Time Frame: 48 weeks ]
5. MELD score [ Time Frame: 48 weeks ]
6. SF36-quality of life [ Time Frame: 48 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 50 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

China, Zhejiang
the First Affiliated Hospital of Zhejiang University-IRB
Hangzhou, Zhejiang, China, 310003

Sponsors and Collaborators

S-Evans Biosciences Co.,Ltd.

Zhejiang University

Zhejiang General Hospital of Armed Police

First Affiliated Hospital of Zhejiang University

Wuhan General Hospital of Guangzhou Military Command

Investigators

Principal Investigator:	Charlie Xiang, Professor	S-Evans Biosciences Co.,Ltd.

More Information

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Additional Information:

North American Indian childhood cirrhosis 

Cirrhosis 

Related Info 

Publications:

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.

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.

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.

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.

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.

Responsible Party:	S-Evans Biosciences Co.,Ltd.
ClinicalTrials.gov Identifier:	NCT01483248 History of Changes
Other Study ID Numbers:	SEB-1115-LC
First Posted:	December 1, 2011
Last Update Posted:	June 7, 2012
Last Verified:	June 2012

Keywords provided by S-Evans Biosciences Co.,Ltd.:

Menstrual blood; Mesenchymal stem cell; Liver cirrhosis

Additional relevant MeSH terms:

Fibrosis; Liver Cirrhosis; Liver Diseases; Digestive System Diseases; Gastrointestinal Diseases; Pathologic Processes; Interferons	Ursodeoxycholic Acid; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Cholagogues and Choleretics; Gastrointestinal Agents