Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis

Phase Ι/Π Study of Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis

Although liver transplantation provide a option to cure patients suffering with decompensated liver cirrhosis this condition, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Bone marrow derived mesenchymal stem cells (BM-MSCs) have been shown to replace hepatocytes in injured liver, effectively rescued experimental liver failure and contributed to liver regeneration, which suggest the novel and promising therapeutic strategy In this study, the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSCs) transplantation for patients with decompensated liver cirrhosis will be evaluated.

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Biological: conventional therapy plus low dose hUC-MSCs treatment; Biological: conventional therapy plus medium dose hUC-MSCs treatment; Biological: conventional therapy plus high dose hUC-MSCs treatment

Detailed Description

To investigate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients of decompensated liver cirrhosis.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200235
      • Shanghai Liver Disease Research Center, the Nanjing Military Command (Shanghai 85 Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent.
• Aged 18-70 years.
• Decompensated liver cirrhosis, Child-Pugh B/C (7-12 points); or Meld score≦21.
• Expecting lifetime is over 2 months.
• Hepatitis B decompensated liver cirrhosis patients need antiviral therapy.

Exclusion Criteria:

• Severe drug allergic history or anaphylaxis.
• Severe problems in other vital organs(e.g. the heart, renal or lungs)
• Severe problems in psychiatric disease,such as Schizophrenia,et al
• Severe bacteria infection.
• Malignancies.
• Alcoholism or drug abuse.
• Plan to have liver transplantation in 3 months.
• Pregnancy
• Candidates who are participating in other study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional plus hUC-MSCs treatment (low dose)	Biological: conventional therapy plus low dose hUC-MSCs treatment; patients will receive the conventional therapy plus low dose hUC-MSCs treatment
Experimental: conventional therapy plus hUC-MSCs treatment （medium dose）	Biological: conventional therapy plus medium dose hUC-MSCs treatment; patients will receive conventional therapy plus medium dose hUC-MSCs treatment
Experimental: conventional therapy plus hUC-MSCs treatment （high dose）	Biological: conventional therapy plus high dose hUC-MSCs treatment; patients will receive conventional therapy plus high dose hUC-MSCs treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	1 year after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Liver function improvement	1 year after treatment
The size of liver and the width of portal venous	1 year after treatment
Incidence of hepatocellular carcinoma within 1 year	1 year after treatment
Child-Pugh score, MELD score,SF36-quality of life (SF36-QOL)	1 year after treatment
The clinical symptom improvement(including appetite, debilitation, abdominal distension, edema of lower limbs, et al )	1 year after treatment

Collaborators and Investigators

• Sponsor: Shenzhen Beike Bio-Technology Co., Ltd.
• Collaborators: No.85 Hospital, Changning, Shanghai, China
• Investigators: Principal Investigator: Chengwei Chen, No.85 Hospital, Changning, Shanghai, China

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: April 21, 2011
• First Submitted That Met QC Criteria: April 25, 2011
• First Posted (Estimate): April 27, 2011

Study Record Updates

• Last Update Posted (Estimate): October 14, 2011
• Last Update Submitted That Met QC Criteria: October 13, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Umbilical Cord Mesenchymal Stem Cells; Decompensated Liver Cirrhosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: BKCR-LD-1.0(2010)