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

NCT01483248 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-06-07

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Zhejiang University

    collaborator OTHER
  • Zhejiang General Hospital of Armed Police

    collaborator OTHER
  • Zhenjiang First People's Hospital

    collaborator OTHER
  • Wuhan General Hospital of Guangzhou Military Command

    collaborator OTHER
  • S-Evans Biosciences Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Charlie Xiang, Professor · S-Evans Biosciences Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-10-31
Completion
2015-10-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01483248 on ClinicalTrials.gov