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Recruiting NCT05093881

Long-term Follow-up of Patients With Alcoholic Liver Cirrhosis Who Had Administered Cellgram-LC in PMC-P-07 Study

No phase Interventional Alcoholic Cirrhosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cellgram-LC.
Who it may be relevant to
Registry conditions: Alcoholic Cirrhosis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

This Long-term follow-up is designed to evaluate the safety of patient with Alcoholic Liver Cirrhosis who had administered Cellgram-LC in PMC-P-07 study.

Detailed description

To evaluate the safety for 60 months after a single dose of Cellgram-LC in patients with alcoholic liver cirrhosis.

Interventions

  • Biological Cellgram-LC
    Patients who had administered Cellgram-LC in PMC-P-07 study

Primary outcome measures

  • Rate of AESI [Time frame: For 5 years]
  • Rate of Liver transplant [Time frame: For 5 years]

Eligibility criteria

Inclusion criteria

  • Those who participated in PMC-P-07 clinical trials and received Cellgram-LC
  • Those who voluntarily agreed in writing to participate in this investigation

Exclusion criteria

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

South Korea · 11 centers
  • Soonchunhyang University Hospital — Bucheon-si
  • Soonchunhyang University Hospital — Cheonan
  • Gangwon National University Hospital — Chuncheon
  • Hallym Univ. Medical Center — Chuncheon
  • Gangneung Asan Hospital — Gangneung-si
  • Eunpyeong St. Mary's Hospital — Seoul
  • Korea University Anam Hospital — Seoul
  • Seoul National University Hospital — Seoul
  • … and 3 more centers

Identifiers

NCT: NCT05093881 · PMC-P-07-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗