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

Alcoholic Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875081
• Other study ID #: PMC-BD-CT-P-002
• Status: Completed
• Phase: Phase 2
• First received: June 7, 2013
• Last updated: March 16, 2016
• Start date: November 2012
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Pharmicell Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT01875211

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholic Liver Cirrhosis
• Liver Cirrhosis
• Liver Cirrhosis, Alcoholic

Intervention

Biological:
• 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 ? Component: Autologous bone marrow-derived mesenchymal stem cell ? Amount: 5X107 cells, 1-time or 2-time injection ? Storage Method: Stored in airtight container at 20~25? Injection Method: Directly inject into liver through hepatic artery

Locations

Country	Name	City	State
Korea, Republic of	Pharmicell Co., Ltd.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pharmicell Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histopathological evaluation (Fibrosis Grade - Laennec Scoring System)		6 month after cell therapy	No
Secondary	Histopathological evaluation score (Ratio of 1-time injection group to 2-time injection group comparison)		6month	No
Secondary	MELD Score		6month	No
Secondary	Child-Pugh grade		6month	No
Secondary	Liver Function Test (ALT, AST, ALP, Albumin, billirubin, r-GT)		6month	No
Secondary	Visual Inspection (Liver volume, Fibroscan)		6month	No