NCT04689152 Clinical Trial to Evaluate the Efficacy and Safety of Cellgram-LC Administration in Patients With Alcoholic Cirrhosis
| NCT ID | NCT04689152 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Pharmicell Co., Ltd. |
| Condition | Alcoholic Cirrhosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-03-02 |
| Primary Completion | 2027-08-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 200 participants in total. It began in 2021-03-02 with a primary completion date of 2027-08-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Moonyoung Kim
PRINCIPAL INVESTIGATOR
Wonju Severance Christian Hospital
Frequently Asked Questions
Who can join the NCT04689152 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 71 Years, studying Alcoholic Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04689152 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 200 participants.
Is NCT04689152 currently recruiting?
Yes, NCT04689152 is actively recruiting participants. Contact the research team at jyjeong@pharmicell.com for enrollment information.
Where is the NCT04689152 trial being conducted?
This trial is being conducted at Bucheon-si, South Korea, Cheonan, South Korea, Chuncheon, South Korea, Chuncheon, South Korea and 7 additional locations.
Who is sponsoring the NCT04689152 clinical trial?
NCT04689152 is sponsored by Pharmicell Co., Ltd.. The principal investigator is Moonyoung Kim at Wonju Severance Christian Hospital. The trial plans to enroll 200 participants.