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

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ClinicalTrials.gov Identifier: NCT01483248
Recruitment Status : Unknown
Verified June 2012 by S-Evans Biosciences Co., Ltd..
Recruitment status was:  Enrolling by invitation
First Posted : December 1, 2011
Last Update Posted : June 7, 2012
Sponsor:
Collaborators:
Zhejiang University
Zhejiang General Hospital of Armed Police
Zhenjiang First People's Hospital
Wuhan General Hospital of Guangzhou Military Command
Information provided by (Responsible Party):
S-Evans Biosciences Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment 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

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2010
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menstruation

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Liver function improvement [ Time Frame: 48 weeks ]
  2. Complications [ Time Frame: 48 weeks ]
    such as fever,anaphylaxis,cough,chest distress,and dyspnea,et al.

  3. The improvement of ascites after 12-week treatment [ Time Frame: 48 weeks ]
  4. Child-Pugh score [ Time Frame: 48 weeks ]
  5. MELD score [ Time Frame: 48 weeks ]
  6. SF36-quality of life [ Time Frame: 48 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483248


Locations
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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 General Hospital of Armed Police
Zhenjiang First People's Hospital
Wuhan General Hospital of Guangzhou Military Command
Investigators
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Principal Investigator: Charlie Xiang, Professor S-Evans Biosciences Co., Ltd.
More Information
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Additional Information:

Publications:

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Responsible Party: S-Evans Biosciences Co., Ltd.
ClinicalTrials.gov Identifier: NCT01483248    
Other Study ID Numbers: SEB-1115-LC
First Posted: December 1, 2011    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 2012
Keywords provided by S-Evans Biosciences Co., Ltd.:
Menstrual blood
Mesenchymal stem cell
Liver cirrhosis
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Gastrointestinal Diseases
Fibrosis
Pathologic Processes
Interferons
 Ursodeoxycholic Acid
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Cholagogues and Choleretics
Gastrointestinal Agents