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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01483248

Enrollment

Registered

2011-12-01

Start date

2010-10-31

Completion date

2015-10-31

Last updated

2012-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive System Disease, Fibrosis, Liver Cirrhosis, Liver Disease

Keywords

Menstrual blood, Mesenchymal stem cell, Liver cirrhosis

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.

Interventions

BIOLOGICALconventional 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.

DRUGConventional therapy plus placebo treatment

25 of the enrolled patients were assigned to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame
Overall Survival	48 weeks

Secondary

Measure	Time frame	Description
Complications	48 weeks	such as fever,anaphylaxis,cough,chest distress,and dyspnea,et al.
The improvement of ascites after 12-week treatment	48 weeks	—
Liver function improvement	48 weeks	—
MELD score	48 weeks	—
SF36-quality of life	48 weeks	—
Child-Pugh score	48 weeks	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026