Safety Study of Liver Regeneration Therapy Using Cultured Autologous BMSCs
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Patients eligible for this study include those with decompensated liver cirrhosis with a
Child-Pugh score ≥7 (Child-Pugh B) in whom further improvement with current medical treatment
is not expected. Other inclusion criteria are age 20 to 75 years and a serum total bilirubin
of 3.0 to 5.0 mg/dL, or if the total bilirubin is <3.0 mg/dL, patients who are still deemed
unsuitable as a candidate for general anesthesia. About 30 mL of autologous bone marrow was
collected from the bilateral iliac crests under local anesthesia, heparin was added after
collection. In addition, at the Center for Regenerative and Cell Therapy at Yamaguchi
University Hospital, a nucleated cell fraction was prepared. Next, a cell suspension was
prepared by adding culture medium, and this was inoculated into a culture flask. After
subculturing for 3 weeks, the cells were infused through a peripheral vein. The primary
endpoint is the incidence of adverse events up to 24 weeks after ABMSC infusion.