Clinical Trial to Evaluate the Efficacy and Safety of Cellgram-LC Administration in Patients With Alcoholic Cirrhosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-02

Study Completion Date

2028-01-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This phase III clinical trial is designed to evaluate the efficacy and safety of autologous Mesenchymal Stem Cells (MSC) injected hepatic artery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Long-term Follow-up Study of Livercellgram in Alcoholic LC Patients Who Completed Livercellgram Phase 2 Study

NCT02806011

Alcoholic Liver Cirrhosis

COMPLETED

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

NCT01875081

Alcoholic Liver Cirrhosis

COMPLETED PHASE2

Long-term Follow-up of Patients With Alcoholic Liver Cirrhosis Who Had Administered Cellgram-LC in PMC-P-07 Study

NCT05093881

Alcoholic Cirrhosis

RECRUITING NA

Long Term Follow up Mesenchymal Stem Cell Therapy for Patients Virus-related Liver Cirrhosis

NCT05080465

Liver Cirrhosis

COMPLETED PHASE3

Mesenchymal Stem Cell Therapy for Liver Cirrhosis

NCT03626090

Liver Cirrhosis

UNKNOWN PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To evaluate the efficacy and efficacy for 60 months after a single dose of Cellgram-LC in patients with alcoholic liver cirrhosis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcoholic Cirrhosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Best Supportive care

Group Type NO_INTERVENTION

No interventions assigned to this group

Injection group: Cellgram-LC

Within 1 month after extracting bone marrow, directly inject 7X10\^7 autologous bone marrow-derived mesenchymal stem cells within liver through the hepatic artery.

Group Type EXPERIMENTAL

Cellgram-LC

Intervention Type BIOLOGICAL

Patients will receive single injection of Cellgram-LC(mesenchymal stem cell) hepatic artery.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cellgram-LC

Patients will receive single injection of Cellgram-LC(mesenchymal stem cell) hepatic artery.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Autologous bone marrow-derived mesenchymal stem cell

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

71 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No