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

NCT01483248 | Unknown Phase 1 DMC

• 1 other identifier: SEB-1115-LC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis; Fibrosis; Liver Disease; Digestive System Disease

Keywords

Menstrual blood; Mesenchymal stem cell; Liver cirrhosis

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  48 weeks

Secondary Outcomes (6)

• Liver function improvement

  48 weeks

• Complications

  48 weeks

• The improvement of ascites after 12-week treatment

  48 weeks

• Child-Pugh score

  48 weeks

• MELD score

  48 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Conventional therapy plus MenSCs treatment

Biological: conventional therapy plus MenSC transplantation

No intervention

ACTIVE COMPARATOR

Conventional therapy plus placebo treatment: Oral or intravenous administration

Drug: Conventional therapy plus placebo treatment

Interventions

conventional therapy plus MenSC transplantation BIOLOGICAL

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.

Also known as: Interferon, Bifendatatum, Ursodeoxycholic Acid, Menstrual blood-derived stem cells(MenSCs)

Intervention

Conventional therapy plus placebo treatment DRUG

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

Also known as: Interferon, Bifendatatum, Ursodeoxycholic Acid

No intervention

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent
• Aged 20 to 50years
• Liver cirrhosis
• Negative pregnancy test

You may not qualify if:

• Pregnant or lactating women
• Malignancies
• Sepsis
• Vital organs failure
• Severe bacteria infection
• Vascular thromboses in the portal or hepatic veins

Sponsors & Collaborators

• S-Evans Biosciences Co., Ltd.: lead
• Zhejiang University: collaborator
• Zhejiang General Hospital of Armed Police: collaborator
• Zhenjiang First People's Hospital: collaborator
• Wuhan General Hospital of Guangzhou Military Command: collaborator

Study Sites (1)

the First Affiliated Hospital of Zhejiang University-IRB

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (5)

• Houlihan DD, Hopkins LJ, Suresh SX, Armstrong MJ, Newsome PN. Autologous bone marrow mesenchymal stem cell transplantation in liver failure patients caused by hepatitis B: short-term and long-term outcomes. Hepatology. 2011 Nov;54(5):1891-2; author reply 1892. doi: 10.1002/hep.24722. No abstract available.

  PMID: 21987440 BACKGROUND

• Peng L, Xie DY, Lin BL, Liu J, Zhu HP, Xie C, Zheng YB, Gao ZL. Autologous bone marrow mesenchymal stem cell transplantation in liver failure patients caused by hepatitis B: short-term and long-term outcomes. Hepatology. 2011 Sep 2;54(3):820-8. doi: 10.1002/hep.24434. Epub 2011 Jul 14.

  PMID: 21608000 BACKGROUND

• Forbes SJ, Newsome PN. New horizons for stem cell therapy in liver disease. J Hepatol. 2012 Feb;56(2):496-9. doi: 10.1016/j.jhep.2011.06.022. Epub 2011 Jul 26.

  PMID: 21798218 BACKGROUND

• Nikeghbalian S, Pournasr B, Aghdami N, Rasekhi A, Geramizadeh B, Hosseini Asl SM, Ramzi M, Kakaei F, Namiri M, Malekzadeh R, Vosough Dizaj A, Malek-Hosseini SA, Baharvand H. Autologous transplantation of bone marrow-derived mononuclear and CD133(+) cells in patients with decompensated cirrhosis. Arch Iran Med. 2011 Jan;14(1):12-7.

  PMID: 21194255 BACKGROUND

• Zhang D, Jiang M, Miao D. Transplanted human amniotic membrane-derived mesenchymal stem cells ameliorate carbon tetrachloride-induced liver cirrhosis in mouse. PLoS One. 2011 Feb 4;6(2):e16789. doi: 10.1371/journal.pone.0016789.

  PMID: 21326862 BACKGROUND

Related Links

• North American Indian childhood cirrhosis
• Cirrhosis
• Related Info

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis; Liver Diseases; Digestive System Diseases

Interventions

Interferons; Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Charlie Xiang, Professor

  S-Evans Biosciences Co., Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: December 1, 2011
• Study Start: October 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2015
• Last Updated: June 7, 2012

Record last verified: 2012-06

Locations

CN (1)