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

Pharmicell

Status and phase: Enrolling; Phase 3

Conditions: Alcoholic Cirrhosis

Treatments: Biological: Cellgram-LC

Study type: Interventional

Funder types: Industry

Identifiers

NCT04689152

PMC-P-07

Details and patient eligibility

About

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

Full description

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

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 71 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Control group

No Intervention group

Description:

Best Supportive care

Injection group: Cellgram-LC

Experimental group

Description:

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

Treatment:

Biological: Cellgram-LC