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Tests treatment safety and results for Alcoholic Cirrhosis
Official title Clinical Trial to Evaluate the Efficacy and Safety of Cellgram-LC Administration in Patients With Alcoholic Cirrhosis
ClinicalTrials.gov ID: NCT04689152
What this study is testing
What is Cellgram-LC?
Cellgram-LC is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for alcoholic cirrhosis.
Also referred to as Autologous bone marrow-derived mesenchymal stem cell.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase III clinical trial is designed to evaluate the efficacy and safety of autologous Mesenchymal Stem Cells (MSC) injected hepatic artery.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 71
You may be able to join if
- At the time of screening, 19 or 70 years
- Patients diagnosed with alcoholic cirrhosis by combining alcohol history, imaging and pathological examination results, and clinical symptoms at...
- Those whose survival period is more than 1 year when judged by the tester
- Those who can perform hepatic artery catheterization by inserting a catheter into the hepatic artery at the judgment of the examiner
- In the case of women of childbearing potential, a person who was confirmed negative in the pregnancy test at screening and agreed to use...
You likely can't join if
- Those with a history of solid cancer including Hepatocellular Carcinoma (HCC) (within 5 years before screening), those who have been diagnosed with...
- Patients who underwent portal systemic shunting in the jugular vein
- Patients with alcohol consumption or hepatotoxic drugs within 6 months prior to screening
- Persons taking high-dose steroids, immunosuppressants, or antimicrobials due to severe infections for at least 1 month of screening
- Those who have major surgical operations, long-term biopsy, or significant trauma as judged by the investigator within 3 months before screening
- Those whose history of gastrointestinal bleeding is confirmed within 10 days of screening
See the full eligibility criteria
- At the time of screening, 19 or 70 years
- 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...
- Those whose survival period is more than 1 year when judged by the tester
- Those who can perform hepatic artery catheterization by inserting a catheter into the hepatic artery at the judgment of the examiner
- 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...
- Those who can conduct clinical trials according to the clinical trial protocol
- A person who has consented in writing to voluntarily participate in this clinical trial
- 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...
- Patients who underwent portal systemic shunting in the jugular vein
- Patients with alcohol consumption or hepatotoxic drugs within 6 months prior to screening
- Persons taking high-dose steroids, immunosuppressants, or antimicrobials due to severe infections for at least 1 month of screening
- Those who have major surgical operations, long-term biopsy, or significant trauma as judged by the investigator within 3 months before screening
- Those whose history of gastrointestinal bleeding is confirmed within 10 days of screening
- 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...
- 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)
- serologic test result (HIV, HAV, HBV, HCV, Syphilis infection) positive factor
- Patients unable to collect bone marrow due to bone marrow disease
- Those with a history of gentamicin hypersensitivity reaction
- Pregnant or lactating women
- Those with substance abuse experience within 1 year before screening
- Those who participated in other clinical trials within one month before screening and administered (or applied) clinical trial drugs (or medical devices)
- Those who previously participated in clinical trials related to cell therapy
- Patients judged to be inappropriate to participate in this clinical trial due to complications, etc., when judged by the investigator before screening or registration
The study team makes the final eligibility decision.
Where it's taking place
- Bucheon-si, South Korea
- Cheonan, South Korea
- Chuncheon, South Korea
- Gangneung-si, South Korea
- Seoul, South Korea
- Wŏnju, South Korea
- Yongin, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 71 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bucheon-si, South Korea; Cheonan, South Korea; Chuncheon, South Korea; Gangneung-si, South Korea; Seoul, South Korea; Wŏnju, South Korea and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.