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Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosis

NCT01440309 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-08-03

No results posted yet for this study

Summary

The study is designed to evaluate the safety and efficacy of intravenous administration of bone marrow derived mesenchymal stem cells for patients with refractory primary biliary cirrhosis (PBC).

Conditions

  • Primary Biliary Cirrhosis

Interventions

BIOLOGICAL

Biological: mesenchymal stem cell

Mesenchymal stem cells,5-50 million/kg, Intravenous infusion, One dosage，whether to give another dosage depending on patients' condition

DRUG

ursodeoxycholic acid

13-15 mg/kg/day, to the end of the study

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Robert Chunhua Zhao, MD, PhD

    lead UNKNOWN

Principal Investigators

  • Fengchun Zhang, MD · Peking Union Medical College Hospital

  • Robert Chunhua Zhao, MD,PhD · Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-11-30
Completion
2013-12-31

Countries

  • China

Study Locations

More Related Trials

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 NCT01440309 on ClinicalTrials.gov