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Clinical Trial to Evaluate the Efficacy and Safety of Cellgram-LC Administration in Patients With Alcoholic Cirrhosis
Sponsor: Pharmicell Co., Ltd.
Summary
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.
Official title: A Multicenter, Randomized, Open-label Phase III Clinical Trial to Evaluate Efficacy and Safety of the Cellgram-LC in Patients With Alcoholic Liver Cirrhosis
Key Details
Gender
All
Age Range
20 Years - 71 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2021-04-19
Completion Date
2029-12-01
Last Updated
2026-09-21
Healthy Volunteers
No
Conditions
Interventions
Cellgram-LC
Participants receive a single injection of 7 × 10\^7 autologous bone marrow-derived mesenchymal stem cells (Cellgram-LC) through the hepatic artery.
Best Supportive Care (BSC)
Participants receive best supportive care.
Locations (15)
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
Yongin, South Korea