About this trial
This study protocol is designed to evaluate the clinical efficacy, safety, and tolerability of HCL001 cell injection in the treatment of decompensated cirrhosis. The aim is to provide stronger evidence for the clinical application of HCL001 cell injection in the treatment of decompensated cirrhosis, thereby attempting to improve patients' survival and quality of life to meet the clinical needs for treating decompensated liver cirrhosis.
Eligibility criteria
Qualifiers
When signing the informed consent form, individuals between the ages of 18 to 75 years (inclusive, including the boundary values) are eligible, and there are no restrictions based on gender.
According to the "Guidelines for the Diagnosis and Treatment of Cirrhosis (2019 Edition)", a diagnosis of decompensated cirrhosis is made.
A Child-Pugh score of 7-12 points (including the threshold) is classified as [insert the corresponding classification as per the provided appendix].
An ECOG performance status score of 0-2 or a Karnofsky Performance Status (KPS) score greater than 60 is considered [insert the corresponding classification or interpretation].
Disqualifiers
Allergic individuals, especially those allergic to any component of HCL001 cell injection or its excipients.
Individuals with concurrent liver cancer or other malignant tumors.
Patients who are unable or unwilling to cooperate or comply with the requirements of the research protocol.
International Normalized Ratio (INR) >2.5 and platelet count (PLT) less than 30 x 10^9/L.
Trial design
Treatments tested in this trial
- HCL001 cell (homologous allogeneic hepatocytes) injection