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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01342250

Enrollment

Registered

2011-04-27

Start date

2010-10-31

Completion date

2011-10-31

Last updated

2011-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis

Keywords

Decompensated Liver Cirrhosis, Umbilical Cord Mesenchymal Stem Cells

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.

Interventions

BIOLOGICALconventional therapy plus low dose hUC-MSCs treatment

patients will receive the conventional therapy plus low dose hUC-MSCs treatment

BIOLOGICALconventional therapy plus medium dose hUC-MSCs treatment

patients will receive conventional therapy plus medium dose hUC-MSCs treatment

BIOLOGICALconventional therapy plus high dose hUC-MSCs treatment

patients will receive conventional therapy plus high dose hUC-MSCs treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS)	1 year after treatment

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026