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

Last updated: March 20, 2024
Sponsor: Pharmicell Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Hyponatremia

Scar Tissue

Hepatic Fibrosis

Treatment

Cellgram-LC

Clinical Study ID

NCT04689152
PMC-P-07
  • Ages 20-71
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. At the time of screening, 19 or 70 years
  2. Patients diagnosed with alcoholic cirrhosis by combining alcohol history, imaging andpathological examination results, and clinical symptoms at screening, and belonging toChild-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 thehepatic artery at the judgment of the examiner
  5. In the case of women of childbearing potential, a person who was confirmed negative inthe pregnancy test at screening and agreed to use contraception* by the methodpermitted 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 clinicaltrial

Exclusion

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 arecurrently undergoing chemotherapy or those whose hepatocellular carcinoma has beenconfirmed 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 toscreening
  4. Persons taking high-dose steroids, immunosuppressants, or antimicrobials due to severeinfections for at least 1 month of screening
  5. Those who have major surgical operations, long-term biopsy, or significant trauma asjudged by the investigator within 3 months before screening
  6. Those whose history of gastrointestinal bleeding is confirmed within 10 days ofscreening
  7. Those whose medical history or accompanying diseases following the screening time isconfirmed
  • If you have not been diagnosed with a malignant blood disease (acute myelogenousleukemia, 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 andautoimmune hepatitis, etc.), weak liver toxicity, non-alcoholic fatty liverdisease , 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 1.5times the upper limit of normal)
  • Acute or chronic infection requiring systemic treatment
  • Severe coagulation disorder (if the tester judges it as a severe coagulationdisorder or one of the following 1 to 3; 1. bleeding predisposition, 2.coagulation, 3. platelet≤50,000/mm3 and INR≥1.5)
  1. serologic test result (HIV, HAV, HBV, HCV, Syphilis infection) positive factor
  2. Patients unable to collect bone marrow due to bone marrow disease
  3. Those with a history of gentamicin hypersensitivity reaction
  4. Pregnant or lactating women
  5. Those with substance abuse experience within 1 year before screening
  6. Those who participated in other clinical trials within one month before screening andadministered (or applied) clinical trial drugs (or medical devices)
  7. Those who previously participated in clinical trials related to cell therapy
  8. Patients judged to be inappropriate to participate in this clinical trial due tocomplications, etc., when judged by the investigator before screening or registration

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Cellgram-LC
Phase: 3
Study Start date:
March 02, 2021
Estimated Completion Date:
January 02, 2028

Study Description

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

Connect with a study center

  • Soonchunhyang University Hospital

    Bucheon,
    Korea, Republic of

    Active - Recruiting

  • Soonchunhyang University Hospital

    Cheonan,
    Korea, Republic of

    Active - Recruiting

  • Gangwon National University Hospital

    ChunCheon,
    Korea, Republic of

    Active - Recruiting

  • Hallym Univ. Medical Center

    ChunCheon,
    Korea, Republic of

    Active - Recruiting

  • Gangneung Asan Hospital

    Gangneung-si,
    Korea, Republic of

    Active - Recruiting

  • Eunpyeong St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Korea University Anam Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Soonchunhyang University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Wonju Severance Christian Hospital

    Wonju,
    Korea, Republic of

    Active - Recruiting

  • Yongin Severance Hospital

    Yongin,
    Korea, Republic of

    Active - Recruiting

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