Can a single stem cell shot save a scarred liver?
NCT ID NCT04689152
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are testing whether a single injection of a patient's own bone marrow stem cells, delivered into the liver's main artery, can help people with alcoholic cirrhosis live longer without needing a liver transplant. The trial enrolls about 200 adults with moderate to severe cirrhosis and compares the stem cell treatment plus standard care against standard care alone. Participants are followed for up to three years to track survival, liver function, and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- autologous bone marrow-derived mesenchymal stem cells (Cellgram-LC)
- What this could lead to
- If it works, a one-time stem cell injection could offer a new way to slow liver failure and delay or avoid the need for a liver transplant in people with alcoholic cirrhosis.
- What could go wrong
- The trial is still testing whether the treatment helps at all, and stem cell therapies for liver disease have had mixed results in earlier studies. Injecting cells into the liver artery carries procedural risks, and not everyone may respond.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2021
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 71 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. At the time of screening, 19 or 70 years 2. Patients diagnosed with alcoholic cirrhosis by combining alcohol history, imaging and pathological examination results, and clinical symptoms at screening, and belonging to Child-Pugh grade B or C (Child-Pugh score of 7 or more) 3. Those whose survival period is more than 1 year when judged by the tester 4. Those who can perform hepatic artery catheterization by inserting a catheter into the hepatic artery at the judgment of the examiner 5. In the case of women of childbearing potential, a person who was confirmed negative in the pregnancy test at screening and agreed to use contraception\* by the method permitted for this clinical trial during the clinical trial 6. Those who can conduct clinical trials according to the clinical trial protocol 7. A person who has consented in writing to voluntarily participate in this clinical trial Exclusion Criteria: 1. Those with a history of solid cancer including Hepatocellular Carcinoma (HCC) (within 5 years before screening), those who have been diagnosed with solid cancer and are currently undergoing chemotherapy or those whose hepatocellular carcinoma has been confirmed by screening tests 2. Patients who underwent portal systemic shunting in the jugular vein 3. Patients with alcohol consumption or hepatotoxic drugs within 6 months prior to screening 4. Persons taking high-dose steroids, immunosuppressants, or antimicrobials due to severe infections for at least 1 month of screening 5. Those who have major surgical operations, long-term biopsy, or significant trauma as judged by the investigator within 3 months before screening 6. Those whose history of gastrointestinal bleeding is confirmed within 10 days of screening 7. Those whose medical history or accompanying diseases following the screening time is confirmed * If you have not been diagnosed with a malignant blood disease (acute myelogenous leukemia, acute lymphocytic leukemia, non-Hodgkins lymphoma, Hodgkins lymphoma, multiple myelopathy) * Severe aplastic anemia * Liver transplant history * Liver diseases of other causes besides alcoholic cirrhosis: hepatitis B and C, autoimmune liver disease (primary cholangitis, primary sclerosing cholangitis and autoimmune hepatitis, etc.), weak liver toxicity, non-alcoholic fatty liver disease , NAFLD), Wilson's disease, iron excess, alpha-1-antitrypsin deficiency, etc.) * Extrahepatic biliary stenosis * Active portal vein or hepatic vein thrombosis * Heart failure or respiratory failure * Severe renal impairment (when the result of serum creatinine test exceeds 1.5 times the upper limit of normal) * Acute or chronic infection requiring systemic treatment * Severe coagulation disorder (if the tester judges it as a severe coagulation disorder or one of the following 1 to 3; 1. bleeding predisposition, 2. coagulation, 3. platelet≤50,000/mm3 and INR≥1.5) 8. serologic test result (HIV, HAV, HBV, HCV, Syphilis infection) positive factor 9. Patients unable to collect bone marrow due to bone marrow disease 10. Those with a history of gentamicin hypersensitivity reaction 11. Pregnant or lactating women 12. Those with substance abuse experience within 1 year before screening 13. Those who participated in other clinical trials within one month before screening and administered (or applied) clinical trial drugs (or medical devices) 14. Those who previously participated in clinical trials related to cell therapy 15. Patients judged to be inappropriate to participate in this clinical trial due to complications, etc., when judged by the investigator before screening or registration
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
13 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Eunpyeong St. Mary's Hospital
RECRUITINGSeoul, South Korea
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Gangnam Severance Hospital
RECRUITINGSeoul, South Korea
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Gangneung Asan Hospital
RECRUITINGGangneung-si, South Korea
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Gangwon National University Hospital
TERMINATEDChuncheon, South Korea
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Hallym Univ. Medical Center
RECRUITINGChuncheon, South Korea
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Korea University Anam Hospital
RECRUITINGSeoul, South Korea
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Korea University Ansan Hospital
RECRUITINGAnsan, South Korea
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Seoul National University Hospital
RECRUITINGSeoul, South Korea
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Seoul St. Mary's Hospital
RECRUITINGSeoul, South Korea
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Severance Hospital
NOT_YET_RECRUITINGSeoul, South Korea
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Soonchunhyang University Hospital
RECRUITINGBucheon-si, South Korea
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Soonchunhyang University Hospital
TERMINATEDCheonan, South Korea
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Soonchunhyang University Hospital
RECRUITINGSeoul, South Korea
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Wonju Severance Christian Hospital
RECRUITINGWŏnju, South Korea
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Yongin Severance Hospital
RECRUITINGYongin, South Korea
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