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Alcoholic Liver CirrhosisPhase 2NCT01875081

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

A Phase 2 study testing Livercellgram in people with Alcoholic Liver Cirrhosis, run by Pharmicell Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Alcoholic Liver Cirrhosis
What is being tested?
Livercellgram
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteSouth Korea
Study dates
Nov 2012to Mar 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Pharmicell Co., Ltd.

    Seoul

Other trials in South Korea

About this study

Official title: 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.

Being tested
Livercellgram
Medical subject headings
Liver Cirrhosis, Alcoholic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LivercellgramBiological

    Also called Autologous bone marrow-derived mesenchymal stem cell

    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
Study groups in NCT01875081
Study groupRoleWhat they receive
Control groupNo interventionBest Supportive care
1-time injection group: LivercellgramExperimentalWithin 1 month after extracting bone marrow, directly inject 5X107 autologous bone marrow-derived mesenchymal stem cells within liver through the hepatic artery.
Receives: Biological: Livercellgram
2-time injection group: LivercellgramExperimentalWithin 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.
Receives: Biological: Livercellgram

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 month after cell therapy

Secondary outcomes (5)

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

    Measured: 6month

  2. MELD Score

    Measured: 6month

  3. Child-Pugh grade

    Measured: 6month

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

    Measured: 6month

  5. Visual Inspection (Liver volume, Fibroscan)

    Measured: 6month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2013 (estimated)
  2. Study startNov 2012
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01875081
Sponsor's protocol ID
PMC-BD-CT-P-002
Status last verified
Mar 2016
First submitted
7 Jun 2013
Last updated
17 Mar 2016
Results posted
No

Publications

  • Han SK, Kim SH, Koh SB, Kim MY. Transplantation of Autologous Bone Marrow-Derived Mesenchymal Stem Cells for the Treatment of Decompensated Liver Cirrhosis: A Real-World Evidence Study in a Population-Based Cohort. Gut Liver. 2026 May 15;20(3):452-457. doi: 10.5009/gnl250016. Epub 2025 Sep 8.

    PubMed 40916722

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Livercellgram in people with Alcoholic Liver Cirrhosis, run by Pharmicell Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Histopathological evaluation (Fibrosis Grade - Laennec Scoring System) (time frame: 6 month after cell therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01875081, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016.

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