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

NCT01875081 | Completed Phase 2

• 1 other identifier: PMC-BD-CT-P-002
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholic Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Histopathological evaluation (Fibrosis Grade - Laennec Scoring System)

  6 month after cell therapy

Secondary Outcomes (5)

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

  6month

• MELD Score

  6month

• Child-Pugh grade

  6month

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

  6month

• Visual Inspection (Liver volume, Fibroscan)

  6month

Study Arms (3)

Control group

NO INTERVENTION

Best Supportive care

1-time injection group: Livercellgram

EXPERIMENTAL

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

2-time injection group: Livercellgram

EXPERIMENTAL

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

Interventions

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

Also known as: Autologous bone marrow-derived mesenchymal stem cell

1-time injection group: Livercellgram; 2-time injection group: Livercellgram

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmicell Co., Ltd.: lead

Study Sites (1)

Pharmicell Co., Ltd.

Seoul, South Korea

Location

MeSH Terms

Conditions

Liver Cirrhosis, Alcoholic

Condition Hierarchy (Ancestors)

Liver Cirrhosis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2013
• First Posted: June 11, 2013
• Study Start: November 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

KR (1)