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

June 6, 2012 updated by: S-Evans Biosciences Co., Ltd.

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

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • the First Affiliated Hospital of Zhejiang University-IRB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Conventional therapy plus MenSCs treatment

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.

Other Names:
  • Interferon
  • Bifendatatum
  • Ursodeoxycholic Acid
  • Menstrual blood-derived stem cells(MenSCs)
ACTIVE_COMPARATOR: No intervention

Conventional therapy plus placebo treatment:

Oral or intravenous administration

25 of the enrolled patients were assigned to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
Other Names:
  • Interferon
  • Bifendatatum
  • Ursodeoxycholic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Charlie Xiang, Professor, S-Evans Biosciences Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ANTICIPATED)

October 1, 2013

Study Completion (ANTICIPATED)

October 1, 2015

Study Registration Dates

First Submitted

November 23, 2011

First Submitted That Met QC Criteria

November 29, 2011

First Posted (ESTIMATE)

December 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 7, 2012

Last Update Submitted That Met QC Criteria

June 6, 2012

Last Verified

June 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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