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

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01483248
• Other study ID #: SEB-1115-LC
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• First received: November 23, 2011
• Last updated: June 6, 2012
• Start date: October 2010
• Est. completion date: October 2015

Study information

• Verified date: June 2012
• Source: S-Evans Biosciences Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Disease
• Digestive System Diseases
• Fibrosis
• Gastrointestinal Diseases
• Liver Cirrhosis
• Liver Disease
• Liver Diseases

Intervention

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.

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.

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Zhejiang University-IRB	Hangzhou	Zhejiang

Sponsors (5)

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

Country where clinical trial is conducted

China, 

References & Publications (5)

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

Outcome

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

External Links

•   Link
•   Cirrhosis
•   North American Indian childhood cirrhosis