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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Liver Cirrhosis, Fibrosis, Liver Disease, Digestive System Disease

Intervention / Treatment
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* Biological: conventional therapy plus MenSC transplantation
* Drug: Conventional therapy plus placebo treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver function improvement |  | 48 weeks | 
| Complications | such as fever,anaphylaxis,cough,chest distress,and dyspnea,et al. | 48 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menstrual blood, Mesenchymal stem cell, Liver cirrhosis