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

S-Evans Biosciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Liver Cirrhosis; Digestive System Disease; Fibrosis; Liver Disease

Treatments: Biological: conventional therapy plus MenSC transplantation; Drug: Conventional therapy plus placebo treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01483248

SEB-1115-LC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intervention

Experimental group

Description:

Conventional therapy plus MenSCs treatment

Treatment:

Biological: conventional therapy plus MenSC transplantation

No intervention

Active Comparator group

Description:

Conventional therapy plus placebo treatment: Oral or intravenous administration

Treatment:

Drug: Conventional therapy plus placebo treatment