Cellgram-LC
BiologicalParticipants receive a single injection of 7 × 10^7 autologous bone marrow-derived mesenchymal stem cells (Cellgram-LC) through the hepatic artery.
NCT Number: NCT04689152
The goal of this clinical trial is to evaluate the efficacy and safety of Cellgram-LC in patients with alcoholic cirrhosis.
The main questions it aims to answer are:
* Is Cellgram-LC superior to best supportive care (BSC) in patients with alcoholic cirrhosis? * What medical problems do participants have after receiving Cellgram-LC compared with BSC?
Participants will:
* Receive a single dose of Cellgram-LC at Week 0 or receive best supportive care according to their assigned study group. * Attend clinic visits for scheduled assessments at Week 4 and Months 3, 6, 9, 12, 18, and 24. * Complete scheduled telephone follow-up at Months 2, 4, 5, 7, 8, 10, 11, 15, 21, 27, 30, 33, and 36. * Be followed for transplant-free survival and other study outcomes.
Interested in participating?
Request Info20 year–71 year
All sexes
Interventional
Phase 3
Korea University Ansan Hospital, Ansan, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants receive a single injection of 7 × 10^7 autologous bone marrow-derived mesenchymal stem cells (Cellgram-LC) through the hepatic artery.
Participants receive best supportive care.
Time frame: For 3 years
Transplant free survival (TFS), the median survival time and 95% confidence interval for each group were presented using the Kaplan-Meier method, and the difference in the survival distribution between the two groups was used as a Cox proportional hazards model corrected for stratification Black.
Time frame: month 24 and 36
For the survival rate, the survival rate and 95% confidence interval at each time point are presented using the Kaplan-Meier method, and the difference in survival rate between the two groups is tested using the Z statistic.
Time frame: week -6 and 0
In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.
CP score was calculated using five factors: hepatic encephalopathy, prothrombin time, bilirubin, serum albumin, and ascites, and the score range was 5-15 points.
In the Child-Pugh grade, scores of the five factors are summed and evaluated as A if it is less than 7 points, B if it is 7-9, and C if it exceeds 9 points.
Time frame: week -6 and 0
In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.
The higher the score, the higher the mortality rate.
Time frame: month 0, 1, 3, 6, 9, 12, 18 and 24
In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.
Time frame: month 0, 6, 12, 18 and 24
In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.
Time frame: week -6 and 0
In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.
Time frame: month -1, 6, 12, 18 and 24
In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.
The higher the score, the higher the quality of life.
Time frame: month -1, 6, 12, 18 and 24
In order to compare the difference between groups in the amount of change in each evaluation variable at the time of visit after cell administration/best supportive therapy compared to the baseline value, covariance analysis (ANCOVA) is performed by setting the baseline time point and stratification factor as a correction variable for each evaluation variable.
The higher the score, the higher the quality of life.
Time frame: week -6, month 3, 6, 9, 12, 18, 24
Two sample t-test or Wilcoxon rank-sum test is performed to test the difference between the two groups for the results of tumor marker test (AFP) at each time point.
Interested in participating?
Request InfoPharmicell Co., Ltd.
Industry
A Multicenter, Randomized, Open-label Phase III Clinical Trial to Evaluate Efficacy and Safety of the Cellgram-LC in Patients With Alcoholic Liver Cirrhosis
Acronym: Cellgram-LC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04106518
Alcohol-Induced Disorders, Alcohol-Related Disorders
Angers, France
View Trial DetailsNCT04250259
Alcohol-Induced Disorders, Alcohol-Related Disorders
Los Angeles, California, United States
View Trial DetailsNCT06866496
Alcohol-Induced Disorders, Alcohol-Related Disorders
Hvidovre, Capital Region, Denmark
View Trial DetailsNCT07678567
Alcohol Use Disorder, Alcohol-Induced Disorders
Louisville, Kentucky, United States
View Trial Details