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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Zhejiang University
Zhejiang Armed Police Hospital
First Affiliated Hospital of Zhejiang University
General Hospital of Guangzhou Military Command of PLA
Information provided by (Responsible Party):
S-Evans Biosciences Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01483248
First received: November 23, 2011
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Liver Cirrhosis
Fibrosis
Liver Disease
Digestive System Disease
Biological: conventional therapy plus MenSC transplantation
Drug: Conventional therapy plus placebo treatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by S-Evans Biosciences Co.,Ltd.:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Liver function improvement [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    such as fever,anaphylaxis,cough,chest distress,and dyspnea,et al.

  • The improvement of ascites after 12-week treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Child-Pugh score [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • MELD score [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • SF36-quality of life [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Conventional therapy plus MenSCs treatment
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.

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

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.
Other Names:
  • Interferon
  • Bifendatatum
  • Ursodeoxycholic Acid

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483248

Locations
China, Zhejiang
the First Affiliated Hospital of Zhejiang University-IRB
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
S-Evans Biosciences Co.,Ltd.
Zhejiang University
Zhejiang Armed Police Hospital
First Affiliated Hospital of Zhejiang University
General Hospital of Guangzhou Military Command of PLA
Investigators
Principal Investigator: Charlie Xiang, Professor S-Evans Biosciences Co.,Ltd.
  More Information

Additional Information:
Publications:
Responsible Party: S-Evans Biosciences Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01483248     History of Changes
Other Study ID Numbers: SEB-1115-LC
Study First Received: November 23, 2011
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration

Keywords provided by S-Evans Biosciences Co.,Ltd.:
Menstrual blood
Mesenchymal stem cell
Liver cirrhosis

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Gastrointestinal Diseases
Interferons
Ursodeoxycholic Acid
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Cholagogues and Choleretics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 16, 2014