Status:
UNKNOWN
Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosis
Lead Sponsor:
Robert Chunhua Zhao, MD, PhD
Collaborating Sponsors:
Peking Union Medical College Hospital
Conditions:
Primary Biliary Cirrhosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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).
Detailed Description
Primary biliary cirrhosis (PBC) is an organ-specific inflammatory disease and characterized by immune mediated destruction of intrahepatic bile ducts, then lead to liver cirrhosis and eventually failu...
Eligibility Criteria
Inclusion
- There must be at least two of the following: a concentration in serum of AMAs at titres of 1:40 or higher; an unexplained rise in the amount of alkaline phosphatase of at least 1•5 times the upper limit of normal for more than 24 weeks; and compatible liver histological findings, specifically non-suppurative cholangitis and interlobular bile duct injury.
- Incomplete response to UDCA at 13-15 mg/kg/day, Criteria for the group of complete responders is including: concentrations of alkaline phosphatase less than three times the upper limit of normal, aspartate aminotransferase less than twice the upper limit of normal, and bilirubin less than 17 μmol/L;and normalisation of abnormal concentrations of bilirubin, albumin, or both.
- Liver pathological staging in 2 or3, Histological staging is based on Ludwig's and Scheuer's classifications
Exclusion
- Patients are receiving any other investigational agents within 4 weeks of study entry
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (defined as invasive fungal infection and progressive CMV viremia), symptomatic congestive heart failure (NYH class III and IV), unstable angina pectoris, or cardiac arrhythmia
- In pregnancy or lactation
- Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible
- HCVpositive ，HBSAg positive or with other liver diseases
- Combined with other autoimmune disease
- Expected survival time is less than one year
- Decompensation of liver function（Child B or C）
- Have a history of allergy or Allergic constitution
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01440309
Start Date
November 1 2011
End Date
December 1 2013
Last Update
August 3 2012
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China