Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04689152

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

20 year–71 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Soonchunhyang University Hospital, Bucheon-si, South Korea

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At the time of screening, 19 or 70 years
  • 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)
  • Those whose survival period is more than 1 year when judged by the tester
  • Those who can perform hepatic artery catheterization by inserting a catheter into the hepatic artery at the judgment of the examiner
  • 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
  • Those who can conduct clinical trials according to the clinical trial protocol
  • A person who has consented in writing to voluntarily participate in this clinical trial

Exclusion criteria

  • 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
  • Patients who underwent portal systemic shunting in the jugular vein
  • Patients with alcohol consumption or hepatotoxic drugs within 6 months prior to screening
  • Persons taking high-dose steroids, immunosuppressants, or antimicrobials due to severe infections for at least 1 month of screening
  • Those who have major surgical operations, long-term biopsy, or significant trauma as judged by the investigator within 3 months before screening
  • Those whose history of gastrointestinal bleeding is confirmed within 10 days of screening
  • 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)
  • serologic test result (HIV, HAV, HBV, HCV, Syphilis infection) positive factor
  • Patients unable to collect bone marrow due to bone marrow disease
  • Those with a history of gentamicin hypersensitivity reaction
  • Pregnant or lactating women
  • Those with substance abuse experience within 1 year before screening
  • Those who participated in other clinical trials within one month before screening and administered (or applied) clinical trial drugs (or medical devices)
  • Those who previously participated in clinical trials related to cell therapy
  • Patients judged to be inappropriate to participate in this clinical trial due to complications, etc., when judged by the investigator before screening or registration

Treatment and study plan

Cellgram-LC

Biological

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

Other names: Autologous bone marrow-derived mesenchymal stem cell

Primary outcomes

  1. Transplant free survival (TFS)

    Time frame: For 3 years

    Transplant free survival (TFS), the median survival time and 95% confidence interval for each group were presented using the Kaplan-Meier method, and the difference in the survival distribution between the two groups was used as a Cox proportional hazards model corrected for stratification Black.

Secondary outcomes

  1. Survival rate

    Time frame: month 24 and 36

    For the survival rate, the survival rate and 95% confidence interval at each time point are presented using the Kaplan-Meier method, and the difference in survival rate between the two groups is tested using the Z statistic.

  2. Change amount of Child-Pugh score

    Time frame: week -6 and 0

    In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.

    CP score was calculated using five factors: hepatic encephalopathy, prothrombin time, bilirubin, serum albumin, and ascites, and the score range was 5-15 points.

    In the Child-Pugh grade, scores of the five factors are summed and evaluated as A if it is less than 7 points, B if it is 7-9, and C if it exceeds 9 points.

  3. Change amount of MELD score

    Time frame: week -6 and 0

    In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.

    The higher the score, the higher the mortality rate.

  4. Change amount of Liver function test

    Time frame: month 0, 1, 3, 6, 9, 12, 18 and 24

    In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.

  5. Change amount of Fibrosis-4

    Time frame: month 0, 6, 12, 18 and 24

    In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.

  6. Change amount of FibroScanⓇ

    Time frame: week -6 and 0

    In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.

  7. Change amount of EQ-5D

    Time frame: month -1, 6, 12, 18 and 24

    In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.

    The higher the score, the higher the quality of life.

  8. Change amount of EQ-VAS

    Time frame: month -1, 6, 12, 18 and 24

    In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.

    The higher the score, the higher the quality of life.

Other outcomes

  1. α-fetoprotein test

    Time frame: week -6, month 3, 6, 9, 12, 18, 24

    Two sample t-test or Wilcoxon rank-sum test is performed to test the difference between the two groups for the results of tumor marker test (AFP) at each time point.

Study contacts

Contact information is provided by the study sponsor or research team.

JIYEOUN JEONG

CONTACT

[email protected]

82-2-3496-0134

Sponsors and collaborators

Lead sponsor

Pharmicell Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Open-label Phase III Clinical Trial to Evaluate Efficacy and Safety of the Cellgram-LC in Patients With Alcoholic Liver Cirrhosis

Acronym: Cellgram-LC

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Dec 30, 2020
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.