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Completed

NCT Number: NCT01875081

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Livercellgram

Biological

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 names: Autologous bone marrow-derived mesenchymal stem cell

Primary outcomes

  1. Histopathological evaluation (Fibrosis Grade - Laennec Scoring System)

    Time frame: 6 month after cell therapy

Secondary outcomes

  1. Histopathological evaluation score (Ratio of 1-time injection group to 2-time injection group comparison)

    Time frame: 6month

  2. MELD Score

    Time frame: 6month

  3. Child-Pugh grade

    Time frame: 6month

  4. Liver Function Test (ALT, AST, ALP, Albumin, billirubin, r-GT)

    Time frame: 6month

  5. Visual Inspection (Liver volume, Fibroscan)

    Time frame: 6month

Sponsors and collaborators

Lead sponsor

Pharmicell Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 11, 2013
Registry last updated
Mar 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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