Clinical Trial to Evaluate the Efficacy and Safety of Cellgram-LC Administration in Patients With Alcoholic Cirrhosis
Sponsor: Pharmicell Co., Ltd. • ClinicalTrials.gov ID: NCT04689152
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The goal of this clinical trial is to evaluate the efficacy and safety of Cellgram-LC in patients with alcoholic cirrhosis. The main questions it aims to answer are: * Is Cellgram-LC superior to best supportive care (BSC) in patients with alcoholic cirrhosis? * What medical problems do participants have after receiving Cellgram-LC compared with BSC? Participants will: * Receive a single dose of Cellgram-LC at Week 0 or receive best supportive care according to their assigned study group. * Attend clinic visits for scheduled assessments at Week 4 and Months 3, 6, 9, 12, 18, and 24. * Complete scheduled telephone follow-up at Months 2, 4, 5, 7, 8, 10, 11, 15, 21, 27, 30, 33, and 36. * Be followed for transplant-free survival and other study outcomes.
Interventions
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Cellgram-LC
(Biological)
Participants receive a single injection of 7 × 10\^7 autologous bone marrow-derived mesenchymal stem cells (Cellgram-LC) through the hepatic artery.
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Best Supportive Care (BSC)
(Other)
Participants receive best supportive care.
Eligibility criteria
Conditions
Locations
- Korea University Ansan Hospital — Ansan, South Korea
- Soonchunhyang University Hospital — Bucheon-si, South Korea
- Soonchunhyang University Hospital — Cheonan, South Korea
- Gangwon National University Hospital — Chuncheon, South Korea
- Hallym Univ. Medical Center — Chuncheon, South Korea
- Gangneung Asan Hospital — Gangneung-si, South Korea
- Eunpyeong St. Mary's Hospital — Seoul, South Korea
- Gangnam Severance Hospital — Seoul, South Korea
- Korea University Anam Hospital — Seoul, South Korea
- Seoul National University Hospital — Seoul, South Korea
- Seoul St. Mary's Hospital — Seoul, South Korea
- Severance Hospital — Seoul, South Korea
- Soonchunhyang University Hospital — Seoul, South Korea
- Wonju Severance Christian Hospital — Wŏnju, South Korea
- Yongin Severance Hospital — Yŏngin, South Korea
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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