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

Primary Purpose

Alcoholic Cirrhosis

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cellgram-LC
Sponsored by
Pharmicell Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcoholic Cirrhosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Soonchunhyang University HospitalRecruiting
  • Soonchunhyang University HospitalRecruiting
  • Gangwon National University HospitalRecruiting
  • Hallym Univ. Medical CenterRecruiting
  • Gangneung Asan HospitalRecruiting
  • Eunpyeong St. Mary's HospitalRecruiting
  • Korea University Anam HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Soonchunhyang University HospitalRecruiting
  • Wonju Severance Christian HospitalRecruiting
  • Yongin Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cellgram-LC

Arm Description

Patients with Alcoholic Liver Cirrhosis who had administered Cellgram-LC in PMC-P-07 study.

Outcomes

Primary Outcome Measures

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)
Rate of Liver transplant
Liver transplant

Secondary Outcome Measures

Full Information

First Posted
October 13, 2021
Last Updated
October 25, 2021
Sponsor
Pharmicell Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05093881
Brief Title
Long-term Follow-up of Patients With Alcoholic Liver Cirrhosis Who Had Administered Cellgram-LC in PMC-P-07 Study
Official Title
Long-term Follow-up of Patients With Alcoholic Liver Cirrhosis Who Had Administered Cellgram-LC in PMC-P-07 Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2021 (Actual)
Primary Completion Date
August 24, 2026 (Anticipated)
Study Completion Date
March 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmicell Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
Detailed Description
To evaluate the safety for 60 months after a single dose of Cellgram-LC in patients with alcoholic liver cirrhosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Cirrhosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cellgram-LC
Arm Type
Experimental
Arm Description
Patients with Alcoholic Liver Cirrhosis who had administered Cellgram-LC in PMC-P-07 study.
Intervention Type
Biological
Intervention Name(s)
Cellgram-LC
Intervention Description
Patients who had administered Cellgram-LC in PMC-P-07 study
Primary Outcome Measure Information:
Title
Rate of AESI
Description
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
Title
Rate of Liver transplant
Description
Liver transplant
Time Frame
For 5 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Those who participated in PMC-P-07 clinical trials and received Cellgram-LC Those who voluntarily agreed in writing to participate in this investigation Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JIYEOUN JEONG
Phone
82-2-3496-0134
Email
jyjeong@pharmicell.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moonyoung Kim
Organizational Affiliation
Wonju Severance Christian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soonchunhyang University Hospital
City
Bucheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-gyun Kim
Email
mcnulty@schmc.ac.kr
Facility Name
Soonchunhyang University Hospital
City
Cheonan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hongsoo kim
Email
khskhs@sch.ac.kr
Facility Name
Gangwon National University Hospital
City
ChunCheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daehee Choi
Email
dhchoi-md@kangwon.ac.kr
Facility Name
Hallym Univ. Medical Center
City
ChunCheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki-tae Seok
Email
diarrhea100@hanmail.net
Facility Name
Gangneung Asan Hospital
City
Gangneung-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gapjin Cheon
Email
1000@gnah.co.kr
Facility Name
Eunpyeong St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sihyeon Bae
Email
baesh@catholic.ac.kr
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeonseok Seo
Email
drseo@korea.ac.kr
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeonghwan Yoon
Email
yoonjh@snu.ac.kr
Facility Name
Soonchunhyang University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaeyoung Jang
Email
jyjang@schmc.ac.kr
Facility Name
Wonju Severance Christian Hospital
City
Wonju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moonyoung Kim
Email
drkimmy@yonsei.ac.kr
First Name & Middle Initial & Last Name & Degree
Sun-gu Baek
Facility Name
Yongin Severance Hospital
City
Yongin
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jakyung Kim
Email
ceciliak@yuhs.ac

12. IPD Sharing Statement

Learn more about this trial

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

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