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

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.

Recruiting

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Key information

Conditions

Alcoholic Liver Cirrhosis Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Fibrosis Liver Cirrhosis Liver Cirrhosis, Alcoholic Liver Diseases Liver Diseases, Alcoholic Pathologic Processes Pathological Conditions, Signs and Symptoms Substance-Related Disorders

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Korea University Ansan Hospital, Ansan, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants who received Cellgram-LC in the PMC-P-07 clinical trial.
Participants who voluntarily provide written informed consent to participate in this study.

Exclusion criteria

None.

Treatment and study plan

Primary outcomes

Incidence of Adverse Event of Special Interest (AESI)

Time frame: From the date of Cellgram-LC administration through 5 years after administration, assessed annually.

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.
Occurrence of Liver Transplantation

Time frame: From the date of Cellgram-LC administration through 5 years after administration, assessed annually.

The number and percentage of participants who undergo liver transplantation will be summarized during the 5-year follow-up period after Cellgram-LC administration.

Study contacts

Contact information is provided by the study sponsor or research team.

YUJEONG KIM

CONTACT

[email protected]

82-2-3496-0137

Sponsors and collaborators

Lead sponsor

Pharmicell Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2031
First posted: Oct 26, 2021
Registry last updated: Sep 21, 2026

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.

Completed