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

Beike Biotech

Status and phase: Completed; Phase 2; Phase 1

Conditions: Liver Cirrhosis

Treatments: Biological: conventional therapy plus medium dose hUC-MSCs treatment; Biological: conventional therapy plus high dose hUC-MSCs treatment; Biological: conventional therapy plus low dose hUC-MSCs treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01342250

BKCR-LD-1.0(2010)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Conventional plus hUC-MSCs treatment (low dose)

Experimental group

Treatment:

Biological: conventional therapy plus low dose hUC-MSCs treatment

conventional therapy plus hUC-MSCs treatment （medium dose）

Experimental group

Treatment:

Biological: conventional therapy plus medium dose hUC-MSCs treatment

conventional therapy plus hUC-MSCs treatment （high dose）

Experimental group

Treatment:

Biological: conventional therapy plus high dose hUC-MSCs treatment