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

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.

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Key information

Conditions

Alcoholic 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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soonchunhyang University Hospital, Bucheon-si, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Cellgram-LC

Biological

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

Primary outcomes

Rate of AESI

Time frame: For 5 years

death, neoplasms or malignancies in tissues or organs, Immune response including exacerbation or new outbreaks of previous autoimmune diseases, Other delayed AE related to Cellgram LC)
Rate of Liver transplant

Time frame: For 5 years

Liver transplant

Study contacts

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

JIYEOUN JEONG

CONTACT

[email protected]

82-2-3496-0134

Sponsors and collaborators

Lead sponsor

Pharmicell Co., Ltd.

Industry

Registry information

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2028
First posted: Oct 26, 2021
Registry last updated: Mar 21, 2024

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.

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