Clinical trial NCT04689152: Clinical Trial to Evaluate the Efficacy and Safety of Cellgram-LC Administration in Patients With Alcoholic Cirrhosis
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Alcoholic Cirrhosis
Lead sponsor: Pharmicell Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-30
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Transplant free survival (TFS)
timeFrame: For 3 years
Secondary outcomes:
measure: Survival rate
timeFrame: month 24 and 36
measure: Change amount of Child-Pugh score
timeFrame: week -6 and 0
measure: Change amount of MELD score
timeFrame: week -6 and 0
measure: Change amount of Liver function test
timeFrame: month 0, 1, 3, 6, 9, 12, 18 and 24
measure: Change amount of Fibrosis-4
timeFrame: month 0, 6, 12, 18 and 24
measure: Change amount of FibroScanⓇ
timeFrame: week -6 and 0
measure: Change amount of EQ-5D
timeFrame: month -1, 6, 12, 18 and 24
measure: Change amount of EQ-VAS
timeFrame: month -1, 6, 12, 18 and 24
Other outcomes:
measure: α-fetoprotein test
timeFrame: week -6, month 3, 6, 9, 12, 18, 24
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Hospital
city: Cheonan
country: Korea, Republic of
facility: Soonchunhyang University Hospital
city: ChunCheon
country: Korea, Republic of
facility: Gangwon National University Hospital
city: ChunCheon
country: Korea, Republic of
facility: Hallym Univ. Medical Center
city: Gangneung-si
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Seoul
country: Korea, Republic of
facility: Eunpyeong St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital
Study officials:
affiliation: Wonju Severance Christian Hospital
name: Moonyoung Kim
role: PRINCIPAL_INVESTIGATOR
References: