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

• Sponsor: Pharmicell Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05093881
• Collaborator: (none)
• Enrollment: 100
• Locations: 11
• Arm: 1
• Anticipated Duration (Months): 79.2
• Patients Per Site: 9.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholic Cirrhosis	Biological: Cellgram-LC	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Long-term Follow-up of Patients With Alcoholic Liver Cirrhosis Who Had Administered Cellgram-LC in PMC-P-07 Study
• Actual Study Start Date: Aug 24, 2021
• Anticipated Primary Completion Date: Aug 24, 2026
• Anticipated Study Completion Date: Mar 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cellgram-LC Patients with Alcoholic Liver Cirrhosis who had administered Cellgram-LC in PMC-P-07 study.	Biological: Cellgram-LC; Patients who had administered Cellgram-LC in PMC-P-07 study

Outcome Measures

Primary Outcome Measures

1. Rate of AESI [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)

2. Rate of Liver transplant [For 5 years]

   Liver transplant

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Soonchunhyang University Hospital	Bucheon		Korea, Republic of
2	Soonchunhyang University Hospital	Cheonan		Korea, Republic of
3	Gangwon National University Hospital	ChunCheon		Korea, Republic of
4	Hallym Univ. Medical Center	ChunCheon		Korea, Republic of
5	Gangneung Asan Hospital	Gangneung-si		Korea, Republic of
6	Eunpyeong St. Mary's Hospital	Seoul		Korea, Republic of
7	Korea University Anam Hospital	Seoul		Korea, Republic of
8	Seoul National University Hospital	Seoul		Korea, Republic of
9	Soonchunhyang University Hospital	Seoul		Korea, Republic of
10	Wonju Severance Christian Hospital	Wonju		Korea, Republic of
11	Yongin Severance Hospital	Yongin		Korea, Republic of

Sponsors and Collaborators

• Pharmicell Co., Ltd.

Investigators

• Principal Investigator: Moonyoung Kim, Wonju Severance Christian Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pharmicell Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05093881
• Other Study ID Numbers: PMC-P-07-01
• First Posted: Oct 26, 2021
• Last Update Posted: Nov 1, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Alcoholic; Fibrosis

Study Results

No Results Posted as of Nov 1, 2021