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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase I Clinical Trial, Randomized, Controlled, to Evaluate the Efficacy and Safety of Therapy With Allogenic Mesenchymal Stem Cells From Bone Marrow for Patients With Refractory Primary Serum level of alkaline phosphatase will be measured at entry, 1 months，3 months, 6 months and 24 months after therapy



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • histological changes in liver biopsies [ Time Frame: 6 months after therapy ]
    Liver biopsy of each patient will be taken before entry into therapeutic trials and at 6 months after therapy.
  • Serum levels of TNF-alpha [ Time Frame: 6 months after therapy ]
    serum levels of TNF-alpha will be assessed before entry into therapeutic trials and at 6 months after therapy
  • changes in fatigue [ Time Frame: 6 months after theraphy ]
    changes in fatigue will be evaluated before test (baseline), 1 month,3 months and 6 months after theraphy by PBC-40 score.
  • The occurrence of cirrhosis and its complications [ Time Frame: 24 months after therapy ]
  • Serum levels of Interleukin [ Time Frame: 6 months after therapy ]
    serum levels of Interleukin will be assessed before entry into therapeutic trials and at 6 months after therapy
  • changes in pruritus severity [ Time Frame: 6 months after therapy ]
    changes in pruritus severity will be evaluated before test (baseline), 1 month,3 months and 6 months after theraphy by VAS score.


Original Secondary Outcome: Same as current

Information By: Chinese Academy of Medical Sciences

Dates:
Date Received: September 20, 2011
Date Started: November 2011
Date Completion: December 2013
Last Updated: August 1, 2012
Last Verified: September 2011