Status:
COMPLETED
REVIVE(Randomized Exploratory Clinical Trial to Evaluate the Safety and Effectiveness of Stem Cell Product in Alcoholic Liver Cirrhosis Patient)
Lead Sponsor:
Pharmicell Co., Ltd.
Conditions:
Alcoholic Liver Cirrhosis
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
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 tha...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01875081
Start Date
November 1 2012
End Date
March 1 2016
Last Update
March 17 2016
Active Locations (1)
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1
Pharmicell Co., Ltd.
Seoul, South Korea