Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
NCT ID:
NCT07276568
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
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Subjects meeting any of the following criteria will be excluded from the study:
1. Presence of severe, life-threatening extrahepatic systemic diseases.
2. Uncontrolled active infection or hemorrhage.
3. Pregnancy or lactation in female patients.
4. History of severe allergic reactions or known hypersensitivity to CiPS-derived cell products or blood products.
5. Inability to undergo phlebotomy due to peripheral vascular collapse.
6. Inability or unwillingness to provide informed consent or comply with the study procedures.
7. Unwillingness to receive CiPS-based therapy.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT07276568
Study Brief:
Protocol Section:
NCT07276568