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

NCT ID: NCT01875081

Last Updated: 2016-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2016-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Best Supportive care

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Livercellgram

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Livercellgram

Intervention Type: 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

Interventions

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Autologous bone marrow-derived mesenchymal stem cell

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmicell Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soon Koo Baik, M.D.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Yonsei University, Wonju Christian Hospital

Si-Hyun Bae, M.D.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

Pharmicell Co., Ltd.

Seoul, , South Korea

Countries

South Korea

Other Identifiers

PMC-BD-CT-P-002

Identifier Type: -

Identifier Source: org_study_id

NCT01875211

Identifier Type: -

Identifier Source: nct_alias