Safety, Tolerability, and Preliminary Efficacy of Hepatocyte-like Cell Injection for the Prevention and Treatment of Small-for-Size Syndrome

Enrolling by invitation · Early Phase 1

Conditions studied: Small-for-size Syndrome

In brief

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.

Key facts

Study ID

NCT07276568

Run by

Zhi-Jun Zhu

People needed

12

Starts

2025-12-17

Expected to finish

2029-12-01

Last updated by the study team

2026-04-15

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be diagnosed with liver failure or small-for-size syndrome based on clinical presentation.
• （Acute Liver Failure (ALF) An acute onset of liver failure characterized by hepatic encephalopathy of grade II or higher within 4 weeks, in a patient without pre-existing liver disease.
• Acute-on-Chronic Liver Failure (ACLF) A complex clinical syndrome characterized by acute deterioration of liver function, triggered by precipitating events, in patients with underlying chronic liver disease (with or without cirrhosis). It manifests as single or multiple organ failure(s) and is associated with high short-term mortality (28-day mortality rate ≥ 15%).
• Chronic Liver Failure (CLF) A state of chronic hepatic decompensation occurring progressively in patients with cirrhosis. It is primarily characterized by recurrent ascites and/or hepatic encephalopathy resulting from progressively declining liver function.
• Small-for-Size Syndrome (SFSS) Diagnosis is established according to the International Liver Transplantation Society (ILTS) 2023 guidelines on SFSS.） ② Patients must agree to undergo intramuscular injection of cells into the rectus sheath.

You may not qualify if…

• Subjects meeting any of the following criteria will be excluded from the study:
• Presence of severe, life-threatening extrahepatic systemic diseases.
• Uncontrolled active infection or hemorrhage.
• Pregnancy or lactation in female patients.
• History of severe allergic reactions or known hypersensitivity to CiPS-derived cell products or blood products.
• Inability to undergo phlebotomy due to peripheral vascular collapse.
• Inability or unwillingness to provide informed consent or comply with the study procedures.
• Unwillingness to receive CiPS-based therapy.

Where it is running

• Beijing Friendship Hospital, Capital Medical University — Beijing, Province, China

Full record on ClinicalTrials.gov

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