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

March 20, 2024 updated by: Pharmicell Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Recruiting
        • Soonchunhyang University Hospital
        • Contact:
      • Cheonan, Korea, Republic of
        • Recruiting
        • Soonchunhyang University Hospital
        • Contact:
      • ChunCheon, Korea, Republic of
      • ChunCheon, Korea, Republic of
      • Gangneung-si, Korea, Republic of
        • Recruiting
        • GangNeung Asan Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Soonchunhyang University Hospital
        • Contact:
      • Seoul, Korea, Republic of
      • Wonju, Korea, Republic of
        • Recruiting
        • Wonju Severance Christian Hospital
        • Contact:
        • Sub-Investigator:
          • Sun-gu Baek
      • Yongin, Korea, Republic of
        • Recruiting
        • Yongin Severance Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Best Supportive care
Experimental: 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.
Biological: Cellgram-LC
Patients will receive single injection of Cellgram-LC(mesenchymal stem cell) hepatic artery.
Other Names:
  • Autologous bone marrow-derived mesenchymal stem cell

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
For 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
month 24 and 36
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.
week -6 and 0
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.
week -6 and 0
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.
month 0, 1, 3, 6, 9, 12, 18 and 24
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.
month 0, 6, 12, 18 and 24
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.
week -6 and 0
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.
month -1, 6, 12, 18 and 24
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.
month -1, 6, 12, 18 and 24

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
week -6, month 3, 6, 9, 12, 18, 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmicell Co., Ltd.

Investigators

  • Principal Investigator: Moonyoung Kim, Wonju Severance Christian Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2021

Primary Completion (Estimated)

August 2, 2027

Study Completion (Estimated)

January 2, 2028

Study Registration Dates

First Submitted

December 21, 2020

First Submitted That Met QC Criteria

December 28, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMC-P-07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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