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
• Status: Recruiting
• Phase: N/A
• 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
• 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:

-

Related Conditions & MeSH terms

• Alcoholic Cirrhosis
• Fibrosis
• Liver Cirrhosis
• Liver Cirrhosis, Alcoholic

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