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

Phase 1

Completed

• Conditions: Liver Cirrhosis
• Interventions: 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

• Registration Number: NCT01342250
• Lead Sponsor: Shenzhen Beike Bio-Technology Co., Ltd.

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2011-04-25
• Study First Posted: 2011-04-27
• Primary Completion: 2011-07
• Status Verified: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2011-10-13
• Last Update Posted: 2011-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional plus hUC-MSCs treatment (low dose)	conventional therapy plus low dose hUC-MSCs treatment	-
conventional therapy plus hUC-MSCs treatment （medium dose）	conventional therapy plus medium dose hUC-MSCs treatment	-
conventional therapy plus hUC-MSCs treatment （high dose）	conventional therapy plus high dose hUC-MSCs treatment	-

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	1 year after treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shanghai Liver Disease Research Center, the Nanjing Military Command (Shanghai 85 Hospital); 🇨🇳 Shanghai, Shanghai, China