Alcoholic Liver CirrhosisNCT05093881
Long-Term Follow-up of Patients With Alcoholic Liver Cirrhosis Treated With Cellgram-LC
An observational study of Alcoholic Liver Cirrhosis, run by Pharmicell Co., Ltd. at 14 sites in South Korea.
Trial summary
The goal of this observational study is to learn about the long-term safety of Cellgram-LC in patients with alcoholic liver cirrhosis who previously received Cellgram-LC in the PMC-P-07 study. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Alcoholic Liver Cirrhosis
- How many people
- 100 participants
- Where
- 14 sitesSouth Korea
- Study dates
- 9 Sep 2021to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with alcoholic liver cirrhosis who previously received Cellgram-LC in the PMC-P-07 clinical trial and voluntarily consent to participate in this long-term follow-up study.
Who may be able to join
- Participants who received Cellgram-LC in the PMC-P-07 clinical trial.
- Participants who voluntarily provide written informed consent to participate in this study.
Who cannot join
- None.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
South Korea14 sites, 12 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan
Sung-hee Kang, +82-31-412-4996, shkang0114@gmail.com
- Recruiting
Soonchunhyang University Hospital
Bucheon-si
Sang-gyun Kim, mcnulty@schmc.ac.kr
- Terminated
Soonchunhyang University Hospital
Cheonan
- Terminated
Gangwon National University Hospital
Chuncheon
- Recruiting
Hallym Univ. Medical Center
Chuncheon
Ki-tae Seok, diarrhea100@hanmail.net
- Recruiting
Gangneung Asan Hospital
Gangneung-si
Gapjin Cheon, 1000@gnah.co.kr
- Recruiting
Eunpyeong St. Mary's Hospital
Seoul
Sihyeon Bae, baesh@catholic.ac.kr
- Recruiting
Gangnam Severance Hospital
Seoul
Hyun-Woong Lee, LHWDOC@yuhs.ac
- Recruiting
Korea University Anam Hospital
Seoul
Yeonseok Seo, drseo@korea.ac.kr
- Recruiting
Seoul National University Hospital
Seoul
Jeonghwan Yoon, yoonjh@snu.ac.kr
- Recruiting
Seoul St. Mary's Hospital
Seoul
Jung-Won Jang, +82-2-2258-6015, garden@catholic.ac.kr
- Recruiting
Soonchunhyang University Hospital
Seoul
Jaeyoung Jang, jyjang@schmc.ac.kr
- Recruiting
Wonju Severance Christian Hospital
Wŏnju
Moonyoung Kim, drkimmy@yonsei.ac.kr
Sun-gu Baek
- Recruiting
Yongin Severance Hospital
Yŏngin
Jakyung Kim, ceciliak@yuhs.ac
About this study
Official title: Long-term Follow-up of Patients With Alcoholic Liver Cirrhosis Who Had Administered Cellgram-LC in PMC-P-07 Study
The goal of this observational study is to learn about the long-term safety of Cellgram-LC in patients with alcoholic liver cirrhosis who previously received Cellgram-LC in the PMC-P-07 study.
The main question it aims to answer is:
- Do adverse event of special interest (AESI) or liver transplantation occur during the 5 years after Cellgram-LC administration?
Participants who previously received Cellgram-LC in the PMC-P-07 study and voluntarily consent to participate in this long-term follow-up study will be followed for 5 years after Cellgram-LC administration through telephone visits to collect information on AESI and liver transplantation.
- Conditions
- Alcoholic Liver Cirrhosis
- Keywords
- Cellgram-LC, Long-Term Follow-up, Adverse Events of Special Interest, Liver Transplantation, Autologous Bone Marrow-Derived Mesenchymal Stem Cell, Mesenchymal Stem Cell
- Medical subject headings
- Liver Cirrhosis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cellgram-LC-treated Participants | Participants who previously received Cellgram-LC in the PMC-P-07 study and voluntarily provide written informed consent to participate in this long-term follow-up study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Event of Special Interest (AESI)
Adverse event of special interest (AESI) include death, neoplasm or malignancy in any tissue or organ, immune reactions including worsening of pre-existing autoimmune disease or new-onset autoimmune disease, and other delayed adverse events considered related to Cellgram-LC.
Measured: From the date of Cellgram-LC administration through 5 years after administration, assessed annually.
Occurrence of Liver Transplantation
The number and percentage of participants who undergo liver transplantation will be summarized during the 5-year follow-up period after Cellgram-LC administration.
Measured: From the date of Cellgram-LC administration through 5 years after administration, assessed annually.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start9 Sep 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmicell Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moonyoung Kim, Principal investigator, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093881
- Sponsor's protocol ID
- PMC-P-07-01
- Status last verified
- Sep 2026
- First submitted
- 13 Oct 2021
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Patients With Alcoholic Liver Cirrhosis Who Had Administered Cellgram-LC in PMC-P-07 Study
- ClinicalTrials.gov ID
- NCT05093881
- Acronym / sponsor ID
- PMC-P-07-01
- Conditions
- Alcoholic Liver Cirrhosis
- Keywords
- Cellgram-LC, Long-Term Follow-up, Adverse Events of Special Interest, Liver Transplantation, Autologous Bone Marrow-Derived Mesenchymal Stem Cell, Mesenchymal Stem Cell
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pharmicell Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the long-term safety of Cellgram-LC in patients with alcoholic liver cirrhosis who previously received Cellgram-LC in the PMC-P-07 study.
The main question it aims to answer is:
- Do adverse event of special interest (AESI) or liver transplantation occur during the 5 years after Cellgram-LC administration?
Participants who previously received Cellgram-LC in the PMC-P-07 study and voluntarily consent to participate in this long-term follow-up study will be followed for 5 years after Cellgram-LC administration through telephone visits to collect information on AESI and liver transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cellgram-LC-treated Participants | – | –Participants who previously received Cellgram-LC in the PMC-P-07 study and voluntarily provide written informed consent to participate in this long-term follow-up study. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with alcoholic liver cirrhosis who previously received Cellgram-LC in the PMC-P-07 clinical trial and voluntarily consent to participate in this long-term follow-up study.
Key inclusion criteria (2 listed)
- Participants who received Cellgram-LC in the PMC-P-07 clinical trial.
- Participants who voluntarily provide written informed consent to participate in this study.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Adverse Event of Special Interest (AESI)
Time frame: From the date of Cellgram-LC administration through 5 years after administration, assessed annually.
Adverse event of special interest (AESI) include death, neoplasm or malignancy in any tissue or organ, immune reactions including worsening of pre-existing autoimmune disease or new-onset autoimmune disease, and other delayed adverse events considered related to Cellgram-LC.
Occurrence of Liver Transplantation
Time frame: From the date of Cellgram-LC administration through 5 years after administration, assessed annually.
The number and percentage of participants who undergo liver transplantation will be summarized during the 5-year follow-up period after Cellgram-LC administration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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RecruitingPhase 3
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Inflammatory and Neuroimmune Guided Investigation of Underlying Fatigue in Patients With Cirrhosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Moonyoung Kim principal investigator
Wonju Severance Christian Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholic Liver Cirrhosis, run by Pharmicell Co., Ltd. at 14 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YUJEONG KIM (82-2-3496-0137, yjkim@pharmicell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Event of Special Interest (AESI) (time frame: From the date of Cellgram-LC administration through 5 years after administration, assessed annually.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.