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

March 20, 2024 updated by: Pharmicell Co., Ltd.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Recruiting
        • Soonchunhyang University Hospital
        • Contact:
      • Cheonan, Korea, Republic of
        • Recruiting
        • Soonchunhyang University Hospital
        • Contact:
      • ChunCheon, Korea, Republic of
      • ChunCheon, Korea, Republic of
      • Gangneung-si, Korea, Republic of
        • Recruiting
        • GangNeung Asan Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Soonchunhyang University Hospital
        • Contact:
      • Seoul, Korea, Republic of
      • Wonju, Korea, Republic of
        • Recruiting
        • WonJu Severance Christian Hospital
        • Contact:
        • Sub-Investigator:
          • Sun-gu Baek
      • Yongin, Korea, Republic of
        • Recruiting
        • Yongin Severance Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
For 5 years
Rate of Liver transplant
Time Frame: For 5 years
Liver transplant
For 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmicell Co., Ltd.

Investigators

  • Principal Investigator: Moonyoung Kim, WonJu Severance Christian Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2021

Primary Completion (Estimated)

August 24, 2026

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

October 13, 2021

First Submitted That Met QC Criteria

October 13, 2021

First Posted (Actual)

October 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMC-P-07-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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