Clinical Trial: REVIVE(Randomized Exploratory Clinical Trial to Evaluate the Safety and Effectiveness of Stem Cell Product in Alcoholic Liver Cirrhosis Patient)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Exploratory Clinical Trial to Evaluate the Safety and Effectiveness of Stem Cell Product in Alcoholic Liver Cirrhosis Patient.

Brief Summary:

If the participant voluntarily agrees to participate in the clinical trial before registration, the investigator conducts a screening test to evaluate the participant's suitability.

A participant that satisfies all selection and exclusion criteria is assigned randomly to a test group (1-time or 2-time injection group) or control group (no-cell therapy group). Participants assigned to the 1-time injection group conduct cell therapy within 1 month after bone marrow aspiration. Before implementing cell therapy, implement hepatic artery catheterization which inserts a catheter into the hepatic artery through the right aorta femoralis and inject 5X107 autologous bone marrow-derived mesenchymal stem cells. Participants assigned to the 2-time injection group store 1-time injection amount of mesenchymal stem cells while being cultivated after sampled from the bone marrow, and will re-inject autologous mesenchymal stem cells within 1 month after first injection.

Participants will make a total of 8 hospital visits on a 4-week interval after registration, and effectiveness and safety will be evaluated based on a fixed procedure on every visit.


Detailed Summary:
Sponsor: Pharmicell Co., Ltd.

Current Primary Outcome: Histopathological evaluation (Fibrosis Grade - Laennec Scoring System) [ Time Frame: 6 month after cell therapy ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Histopathological evaluation score (Ratio of 1-time injection group to 2-time injection group comparison) [ Time Frame: 6month ]
  • MELD Score [ Time Frame: 6month ]
  • Child-Pugh grade [ Time Frame: 6month ]
  • Liver Function Test (ALT, AST, ALP, Albumin, billirubin, r-GT) [ Time Frame: 6month ]
  • Visual Inspection (Liver volume, Fibroscan) [ Time Frame: 6month ]


Original Secondary Outcome: -Histopathological evaluation score (Ratio of 1-time injection group to 2-time injection group comparison) -MELD Score -Child-Pugh grade -Liver Function Test (ALT, AST, ALP, Albumin, billirubin, r-GT) -Visual Inspection (Liver volume, Fibroscan) [ Time Frame: 6month ]

Information By: Pharmicell Co., Ltd.

Dates:
Date Received: June 7, 2013
Date Started: November 2012
Date Completion:
Last Updated: March 16, 2016
Last Verified: March 2016