Alcoholic Liver Cirrhosis Clinical Trial
Official title:
A Phase I, Open-Label, Single-Dose Study to Evaluate the Safety and Efficacy of Hepatic Artery Injection of Autologous Human Bone Marrow-Derived Mesenchymal Stem Cells (Cellgram™) in Patients With Alcoholic Liver Cirrhosis
This study is to evaluate the safety and efficacy of a single dose of Cellgram™ delivered via hepatic artery in patients with decompensated alcoholic liver cirrhosis.
After providing written informed consent, subjects will return to the study center for further evaluation and to have their Bone marrow harvested by an experienced hematologist or interventional radiologist. Within approximately 1 month (30 ± 7 days) after Bone marrow aspiration, study participants will be admitted to the study center on Day 1. At the study center, the participant will undergo hepatic artery catheterization by an interventional radiologist who will inject a single dose of Cellgram™. Participants will remain as in-patients and be observed for 24 hours post-infusion. Following discharge, participants will periodically return to the study center for study assessment visits over a period of 1 year. When a suitable candidate is identified by the Investigator, the Investigator or designated healthcare professional will ask the patient about his/her willingness to be included in the clinical study. Following this, patients will be allowed sufficient time, in their own opinion, to consider study entry, and will be offered the opportunity to ask any further questions prior to signing the informed consent form. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01741090 -
The Effectiveness and Safety for Mesenchymal Stem Cell for Alcoholic Liver Cirrhosis
|
Phase 2 | |
| Recruiting |
NCT00239096 -
Prevention of Decompensation in Liver Cirrhosis
|
Phase 4 | |
| Completed |
NCT01875081 -
REVIVE(Randomized Exploratory Clinical Trial to Evaluate the Safety and Effectiveness of Stem Cell Product in Alcoholic Liver Cirrhosis Patient)
|
Phase 2 | |
| Completed |
NCT02806011 -
Long-term Follow-up Study of Livercellgram in Alcoholic LC Patients Who Completed Livercellgram Phase 2 Study
|
||
| Completed |
NCT01591200 -
Dose Finding Study to Assess Safety and Efficacy of Stem Cells in Liver Cirrhosis
|
Phase 2 |