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Safety and Efficacy of Human Mesenchymal Stem Cells for Treatment of Liver Failure

NCT01218464 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2013-05-31

No results posted yet for this study

Summary

Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. and liver transplantation is the only available therapeutic option for patients suffering with this condition. However, lack of donors, surgical complications, rejection, and high cost are serious problems. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. In this study, the patients with LF will undergo administration of human umbilical cord mesenchymal stem cells (UC-MSCs) via peripheral vein transfusion to evaluate the safty and efficacy of UC-MSCs treatment for these patients.

Conditions

  • Liver Failure
  • Mesenchymal Stem Cells

Interventions

DRUG

Conventional plus MSC treatment

Participants received conventional treatment and taken i.v., once per 4 week, at a dose of 0.5\*10E6 MSC/kg body for 12 weeks.

DRUG

Conventional plus pacebo treatment

Participants received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 12 weeks.

Sponsors & Collaborators

  • Beijing 302 Hospital

    lead OTHER

Principal Investigators

  • Fu-Sheng Wang, Professor · Beijing 302 Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01218464 on ClinicalTrials.gov