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

ConditionAlcoholic Cirrhosis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorPharmicell Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Those who participated in PMC-P-07 clinical trials and received Cellgram-LC

Those who voluntarily agreed in writing to participate in this investigation

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: Cellgram-LCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Rate of AESI

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)

Time frame

For 5 years

Rate of Liver transplant

Liver transplant

Time frame

For 5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pharmicell Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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