Long-Term Follow-up of Patients With Alcoholic Liver Cirrhosis Treated With Cellgram-LC
ConditionAlcoholic Liver Cirrhosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-70
SponsorPharmicell Co., Ltd.
About this trial
The goal of this observational study is to learn about the long-term safety of Cellgram-LC in patients with alcoholic liver cirrhosis who previously received Cellgram-LC in the PMC-P-07 study.
The main question it aims to answer is:
\- Do adverse event of special interest (AESI) or liver transplantation occur during the 5 years after Cellgram-LC administration?
Participants who previously received Cellgram-LC in the PMC-P-07 study and voluntarily consent to participate in this long-term follow-up study will be followed for 5 years after Cellgram-LC administration through telephone visits to collect information on AESI and liver transplantation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants who received Cellgram-LC in the PMC-P-07 clinical trial.
Participants who voluntarily provide written informed consent to participate in this study.
Disqualifiers
None
Trial population
Patients with alcoholic liver cirrhosis who previously received Cellgram-LC in the PMC-P-07 clinical trial and voluntarily consent to participate in this long-term follow-up study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Cellgram-LC-treated Participants
Trial outcomes
Primary outcomes
1
Incidence of Adverse Event of Special Interest (AESI)
Adverse event of special interest (AESI) include death, neoplasm or malignancy in any tissue or organ, immune reactions including worsening of pre-existing autoimmune disease or new-onset autoimmune disease, and other delayed adverse events considered related to Cellgram-LC.
Time frame
From the date of Cellgram-LC administration through 5 years after administration, assessed annually.2
Occurrence of Liver Transplantation
The number and percentage of participants who undergo liver transplantation will be summarized during the 5-year follow-up period after Cellgram-LC administration.
Time frame
From the date of Cellgram-LC administration through 5 years after administration, assessed annually.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov