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NCT05093881 Clinical Trial

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

Alcoholic Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05093881
Other study ID # PMC-P-07-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 24, 2021
Est. completion date March 31, 2028

Study information
Verified date March 2024
Source Pharmicell Co., Ltd.
Contact JIYEOUN JEONG
Phone 82-2-3496-0134
Email jyjeong@pharmicell.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date March 31, 2028
Est. primary completion date August 24, 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Those who participated in PMC-P-07 clinical trials and received Cellgram-LC 2. Those who voluntarily agreed in writing to participate in this investigation Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Soonchunhyang University Hospital Bucheon
Korea, Republic of Soonchunhyang University Hospital Cheonan
Korea, Republic of Gangwon National University Hospital ChunCheon
Korea, Republic of Hallym Univ. Medical Center ChunCheon
Korea, Republic of Gangneung Asan Hospital Gangneung-si
Korea, Republic of Eunpyeong St. Mary's Hospital Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Soonchunhyang University Hospital Seoul
Korea, Republic of Wonju Severance Christian Hospital Wonju
Korea, Republic of Yongin Severance Hospital Yongin

Sponsors (1)
Lead Sponsor Collaborator
Pharmicell Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) For 5 years
Primary Rate of Liver transplant Liver transplant For 5 years
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