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

Primary Purpose

Alcoholic Liver Cirrhosis

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Livercellgram
Sponsored by
Pharmicell Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholic Liver Cirrhosis

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pharmicell Co., Ltd.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control group

1-time injection group: Livercellgram

2-time injection group: Livercellgram

Arm Description

Best Supportive care

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 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.

Outcomes

Primary Outcome Measures

Histopathological evaluation (Fibrosis Grade - Laennec Scoring System)

Secondary Outcome Measures

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)

Full Information

First Posted
June 7, 2013
Last Updated
March 16, 2016
Sponsor
Pharmicell Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01875081
Brief Title
REVIVE(Randomized Exploratory Clinical Trial to Evaluate the Safety and Effectiveness of Stem Cell Product in Alcoholic Liver Cirrhosis Patient)
Official Title
Randomized Exploratory Clinical Trial to Evaluate the Safety and Effectiveness of Stem Cell Product in Alcoholic Liver Cirrhosis Patient.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmicell Co., Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Liver Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Best Supportive care
Arm Title
1-time injection group: Livercellgram
Arm Type
Experimental
Arm Description
Within 1 month after extracting bone marrow, directly inject 5X107 autologous bone marrow-derived mesenchymal stem cells within liver through the hepatic artery.
Arm Title
2-time injection group: Livercellgram
Arm Type
Experimental
Arm Description
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 Type
Biological
Intervention Name(s)
Livercellgram
Other Intervention Name(s)
Autologous bone marrow-derived mesenchymal stem cell
Intervention Description
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
Primary Outcome Measure Information:
Title
Histopathological evaluation (Fibrosis Grade - Laennec Scoring System)
Time Frame
6 month after cell therapy
Secondary Outcome Measure Information:
Title
Histopathological evaluation score (Ratio of 1-time injection group to 2-time injection group comparison)
Time Frame
6month
Title
MELD Score
Time Frame
6month
Title
Child-Pugh grade
Time Frame
6month
Title
Liver Function Test (ALT, AST, ALP, Albumin, billirubin, r-GT)
Time Frame
6month
Title
Visual Inspection (Liver volume, Fibroscan)
Time Frame
6month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or clinically diagnosed as alcoholic liver cirrhosis Classified as Child-Pugh grade B or C Age of 20 ~ 70 years Capable of conducting hepatic artery catheterization which inserts a catheter up to the hepatic artery In the case of fertile women, confirmed as negative in pregnancy test when screening, and agreed to avoid pregnancy during the trial period 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) Patient who can agree to participate in the clinical trial by oneself or by one's legal representative Able to conduct the clinical trial according to the protocol Exclusion Criteria: Diagnosed with malignant hematologic disease (acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin lymphoma, Hodgkin lymphoma, multiple myeloma) and not cured from it Patient with severe aplastic anemia Has a medical record of solid cancer(within 5 years prior to screening), or diagnosed with solid cancer and currently receiving cancer treatment Incapable of conducting hepatic artery Patient who consumed alcohol and took hepatotoxic drugs within 6 months prior to registration Has continuously taken a large amount of steroids or antibiotics for 1 month prior to registration Judged by a researcher to have had major orthopedic surgery, organ biopsy, or similar external injury within 3 months prior to registration Evidence of active autoimmune liver disease Patient with extrahepatic biliary stricture Patient who conducted transjugular intrahepatic portosystemic shunt Has active thrombosis of the portal or hepatic veins Patient with sepsis Patient who suffers heart, renal, respiratory failure Patient who is positive in pathogenic test (HIV, Syphilis,HBV,HCV) Pregnant or lactating woman Patient who cannot adapt to the protocol and follow-up observation Patient who has experienced drug abuse for the past 1 year Participated in the other clinical trials within 30 days before registration Patient with any disease or condition which the investigator feel would interfere with trial or the safety of the subject
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soon Koo Baik, M.D.,Ph.D
Organizational Affiliation
Yonsei University, Wonju Christian Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Si-Hyun Bae, M.D.,Ph.D
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pharmicell Co., Ltd.
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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