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

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ClinicalTrials.gov Identifier: NCT01875081
Recruitment Status : Completed
First Posted : June 11, 2013
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Pharmicell Co., Ltd.

Tracking Information
First Submitted Date  ICMJE June 7, 2013
First Posted Date  ICMJE June 11, 2013
Last Update Posted Date March 17, 2016
Study Start Date  ICMJE November 2012
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2013)
Histopathological evaluation (Fibrosis Grade - Laennec Scoring System) [ Time Frame: 6 month after cell therapy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01875081 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2013)
  • 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 Measures  ICMJE
 (submitted: June 7, 2013)
-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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE REVIVE(Randomized Exploratory Clinical Trial to Evaluate the Safety and Effectiveness of Stem Cell Product in Alcoholic Liver Cirrhosis Patient)
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alcoholic Liver Cirrhosis
Intervention  ICMJE Biological: Livercellgram

Livercellgram

  • Dosage form and appearance: White cell suspension is filled in a clear plastic syringe, and fixed with an occlude on the prefilled syringe tip ② Component: Autologous bone marrow-derived mesenchymal stem cell ③ Amount: 5X107 cells, 1-time or 2-time injection ④ Storage Method: Stored in airtight container at 20~25℃

    • Injection Method: Directly inject into liver through hepatic artery
Other Name: Autologous bone marrow-derived mesenchymal stem cell
Study Arms  ICMJE
  • No Intervention: Control group
    Best Supportive care
  • Experimental: 1-time injection group: Livercellgram
    Within 1 month after extracting bone marrow, directly inject 5X107 autologous bone marrow-derived mesenchymal stem cells within liver through the hepatic artery.
    Intervention: Biological: Livercellgram
  • Experimental: 2-time injection group: Livercellgram
    Within 1 month after extracting bone marrow, directly inject 5X107 autologous bone marrow-derived mesenchymal stem cells within liver through the hepatic artery. Within 1 month after cell injection, re-inject autologous bone marrow-derived mesenchymal stem cells.
    Intervention: Biological: Livercellgram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2013)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically or clinically diagnosed as alcoholic liver cirrhosis
  2. Classified as Child-Pugh grade B or C
  3. Age of 20 ~ 70 years
  4. Capable of conducting hepatic artery catheterization which inserts a catheter up to the hepatic artery
  5. In the case of fertile women, confirmed as negative in pregnancy test when screening, and agreed to avoid pregnancy during the trial period
  6. Women capable of pregnancy must satisfy the following conditions; Has been through menopause for at least 1 year, has no possibility of pregnancy via surgery/procedure, or effectively used acceptable contraceptive methods (Intrauterine device-loop, mirena, diaphragm or condom/femidom, oral contraceptive pills, non-oral contraceptives)
  7. Patient who can agree to participate in the clinical trial by oneself or by one's legal representative
  8. Able to conduct the clinical trial according to the protocol

Exclusion Criteria:

  1. Diagnosed with malignant hematologic disease (acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin lymphoma, Hodgkin lymphoma, multiple myeloma) and not cured from it
  2. Patient with severe aplastic anemia
  3. Has a medical record of solid cancer(within 5 years prior to screening), or diagnosed with solid cancer and currently receiving cancer treatment
  4. Incapable of conducting hepatic artery
  5. Patient who consumed alcohol and took hepatotoxic drugs within 6 months prior to registration
  6. Has continuously taken a large amount of steroids or antibiotics for 1 month prior to registration
  7. Judged by a researcher to have had major orthopedic surgery, organ biopsy, or similar external injury within 3 months prior to registration
  8. Evidence of active autoimmune liver disease
  9. Patient with extrahepatic biliary stricture
  10. Patient who conducted transjugular intrahepatic portosystemic shunt
  11. Has active thrombosis of the portal or hepatic veins
  12. Patient with sepsis
  13. Patient who suffers heart, renal, respiratory failure
  14. Patient who is positive in pathogenic test (HIV, Syphilis,HBV,HCV)
  15. Pregnant or lactating woman
  16. Patient who cannot adapt to the protocol and follow-up observation
  17. Patient who has experienced drug abuse for the past 1 year
  18. Participated in the other clinical trials within 30 days before registration
  19. Patient with any disease or condition which the investigator feel would interfere with trial or the safety of the subject
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01875081
Other Study ID Numbers  ICMJE PMC-BD-CT-P-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pharmicell Co., Ltd.
Study Sponsor  ICMJE Pharmicell Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Soon Koo Baik, M.D.,Ph.D Yonsei University, Wonju Christian Hospital
Principal Investigator: Si-Hyun Bae, M.D.,Ph.D The Catholic University of Korea
PRS Account Pharmicell Co., Ltd.
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP