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RECRUITING
NCT04689152
PHASE3

Clinical Trial to Evaluate the Efficacy and Safety of Cellgram-LC Administration in Patients With Alcoholic Cirrhosis

Sponsor: Pharmicell Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Cellgram-LC

Participants receive a single injection of 7 × 10\^7 autologous bone marrow-derived mesenchymal stem cells (Cellgram-LC) through the hepatic artery.

OTHER

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