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

Phase 1

• Conditions: Liver Cirrhosis; Fibrosis; Liver Disease; Digestive System Disease
• Interventions: Biological: conventional therapy plus MenSC transplantation; Drug: Conventional therapy plus placebo treatment

• Registration Number: NCT01483248
• Lead Sponsor: S-Evans Biosciences Co., Ltd.

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-11-23
• Study First Submitted QC: 2011-11-29
• Study First Posted: 2011-12-01
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-06
• Last Update Posted: 2012-06-07
• Primary Completion: 2013-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	conventional therapy plus MenSC transplantation	Conventional therapy plus MenSCs treatment
No intervention	Conventional therapy plus placebo treatment	Conventional therapy plus placebo treatment: Oral or intravenous administration

Primary Outcome Measures

Name	Time	Method
Overall Survival	48 weeks

Secondary Outcome Measures

Name	Time	Method
Liver function improvement	48 weeks
Complications	48 weeks	such as fever,anaphylaxis,cough,chest distress,and dyspnea,et al.
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

Trial Locations

Locations (1)

the First Affiliated Hospital of Zhejiang University-IRB; 🇨🇳 Hangzhou, Zhejiang, China