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Long-Term Follow-up of Patients With Alcoholic Liver Cirrhosis Treated With Cellgram-LC

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Aug 24, 2026 → Dec 31, 2026
Primary endpoint reworded 2 of 2 changed
See other at-risk trials from Pharmicell Co., Ltd.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 9 more changesShow less
    • Phase changed: not applicable → not specified
    • Primary completion pushed from Aug 24, 2026 to Dec 31, 2026
    • Trial sites expanded: 11 → 14 locations
    • Study completion pushed from Mar 31, 2028 to Dec 31, 2031
    • Interventions modified
    • Start date: Aug 24, 2021 to Sep 9, 2021
    • Study description shortened, about 19 words
    • Eligibility criteria expanded, about 3 words
    • Study title shortened, about 4 words
  2. Re-verified, no change to tracked fieldsv3
  3. Primary endpoints revised (2)
    • Eligibility criteria revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05093881
Lead Sponsor Pharmicell Co., Ltd.
Conditions
(from sponsor)		 Alcoholic Liver Cirrhosis
Related terms Liver Cirrhosis, Alcoholic
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov