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

This study is currently recruiting participants.
Verified October 2013 by Pharmicell Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Pharmicell Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01875081
First received: June 7, 2013
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Alcoholic Liver Cirrhosis
Biological: Livercellgram
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Exploratory Clinical Trial to Evaluate the Safety and Effectiveness of Stem Cell Product in Alcoholic Liver Cirrhosis Patient.

Resource links provided by NLM:


Further study details as provided by Pharmicell Co., Ltd.:

Primary Outcome Measures:
  • Histopathological evaluation (Fibrosis Grade - Laennec Scoring System) [ Time Frame: 6 month after cell therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Histopathological evaluation score (Ratio of 1-time injection group to 2-time injection group comparison) [ Time Frame: 6month ] [ Designated as safety issue: No ]
  • MELD Score [ Time Frame: 6month ] [ Designated as safety issue: No ]
  • Child-Pugh grade [ Time Frame: 6month ] [ Designated as safety issue: No ]
  • Liver Function Test (ALT, AST, ALP, Albumin, billirubin, r-GT) [ Time Frame: 6month ] [ Designated as safety issue: No ]
  • Visual Inspection (Liver volume, Fibroscan) [ Time Frame: 6month ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: November 2012
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01875081

Contacts
Contact: Soon Koo Baik, M.D.,Ph.D baiksk@yonsei.ac.kr
Contact: Si-Hyun Bae, M.D.,Ph.D baesh@catholic.ac.kr

Locations
Korea, Republic of
Pharmicell Co., Ltd. Recruiting
Seoul, Korea, Republic of
Contact: WanSeok Joo, Ph.D       zzwan@pharmicell.com   
Contact: Sunmi Park       smpark@pharmicell.com   
Sponsors and Collaborators
Pharmicell Co., Ltd.
Investigators
Principal Investigator: Soon Koo Baik, M.D.,Ph.D Yonsei University, Wonju Christian Hospital
Principal Investigator: Si-Hyun Bae, M.D.,Ph.D Catholic University,Seoul St. Mary's Hospital
  More Information

No publications provided

Responsible Party: Pharmicell Co., Ltd.
ClinicalTrials.gov Identifier: NCT01875081     History of Changes
Obsolete Identifiers: NCT01875211
Other Study ID Numbers: PMC-BD-CT-P-002
Study First Received: June 7, 2013
Last Updated: October 23, 2013
Health Authority: Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Cirrhosis, Alcoholic
Liver Diseases
Digestive System Diseases
Pathologic Processes
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on April 16, 2014