To evaluate the safety, tolerability, and preliminary efficacy of rectus sheath injection of hepatocyte-like cells in the treatment and prevention of small-for-size syndrome, with the ultimate goal of improving patient survival.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Incidence of adverse events related to hepatocyte-like cell injection
Timeframe: within 7 days after injection
Plasma Ammonia
Timeframe: Blood samples will be collected at before treatment, 6 hours, 12 hours, and on days 1, 3, 7, 14, as well as at months 1, 2, and 3 post-treatment.
Serum Direct Bilirubin
Timeframe: Blood samples will be collected at before treatment, 6 hours, 12 hours, and on days 1, 3, 7, 14, as well as at months 1, 2, and 3 post-treatment.
Serum Total Bilirubin
Timeframe: Blood samples will be collected at before treatment, 6 hours, 12 hours, and on days 1, 3, 7, 14, as well as at months 1, 2, and 3 post-treatment.
Serum Aspartate Aminotransferase (AST)
Timeframe: Blood samples will be collected at before treatment, 6 hours, 12 hours, and on days 1, 3, 7, 14, as well as at months 1, 2, and 3 post-treatment.
Serum Alanine Aminotransferase (ALT)
Timeframe: Blood samples will be collected at before treatment, 6 hours, 12 hours, and on days 1, 3, 7, 14, as well as at months 1, 2, and 3 post-treatment.
Incidence of short-term adverse events related to the hepatocyte-like cell product
Timeframe: within 1 month after injection
Incidence, severity, and prognosis of small-for-size syndrome
Timeframe: Within 3 months after injection
Coagulation Function
Timeframe: Blood samples will be collected before injection, at 6 hours, 12 hours, and on days 1, 3, 7, 14, as well as at months 1, 2, and 3 post-injection.