Long-term follow-up for patients with alcoholic liver cirrhosis treated with Cellgram-LC
Long-term Follow-up of Patients With Alcoholic Liver Cirrhosis Who Had Administered Cellgram-LC in PMC-P-07 Study
This study is testing the long-term safety of a treatment called Cellgram-LC in people with alcoholic liver cirrhosis who have already received it in a previous trial.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Pharmicell Co., Ltd. Industry-sponsored |
| Locations | 11 sites (Bucheon-si and 10 other locations) |
| Trial ID | NCT05093881 on ClinicalTrials.gov |
What this trial studies
This study evaluates the long-term safety of Cellgram-LC in patients with alcoholic liver cirrhosis who previously participated in the PMC-P-07 clinical trial. Participants will be monitored for 60 months following a single dose of the treatment to assess any potential adverse effects or complications. The study aims to gather comprehensive data on the safety profile of Cellgram-LC over an extended period.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who previously participated in the PMC-P-07 trial and received Cellgram-LC.
Not a fit: Patients who did not participate in the PMC-P-07 trial or did not receive Cellgram-LC will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety of Cellgram-LC, potentially leading to improved treatment options for patients with alcoholic liver cirrhosis.
How similar studies have performed: While this study focuses on long-term safety, similar studies evaluating the safety of treatments in chronic conditions have shown promising results, although this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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: \-
Where this trial is running
Bucheon-si and 10 other locations
- Soonchunhyang University Hospital — Bucheon-si, South Korea (Recruiting)
- Soonchunhyang University Hospital — Cheonan, South Korea (Recruiting)
- Gangwon National University Hospital — Chuncheon, South Korea (Recruiting)
- Hallym Univ. Medical Center — Chuncheon, South Korea (Recruiting)
- Gangneung Asan Hospital — Gangneung-si, South Korea (Recruiting)
- Eunpyeong St. Mary's Hospital — Seoul, South Korea (Recruiting)
- Korea University Anam Hospital — Seoul, South Korea (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Soonchunhyang University Hospital — Seoul, South Korea (Recruiting)
- Wonju Severance Christian Hospital — Wŏnju, South Korea (Recruiting)
- Yongin Severance Hospital — Yŏngin, South Korea (Recruiting)
Study contacts
- Principal investigator: Moonyoung Kim — Wonju Severance Christian Hospital
- Study coordinator: Jiyeoun Jeong
- Email: jyjeong@pharmicell.com
- Phone: 82-2-3496-0134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.