The study is a single-center, single-arm, open-label, dose-escalation clinical study, to evaluate the tolerability, safety and preliminary efficacy of CUD005 injection in patients with cirrhosis
The study was designed according to the 3+3 principle, with a total of 3 dose levels and dose escalation. Low-dose group: 5.0×107 cells/time; Medium-dose group: 1.5×108 cells/time; High-dose group: 5.0×108 cells/time. Subjects were sequentially placed in 3 different dose groups administered as a single peripheral intravenous dose. According to the enrollment restriction design, a total of a minimum of 9 subjects are expected to be enrolled, and the final sample size depends on the number of DLT, the number of dose groups ascended before DLT is observed, and the MTD is determined.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Subjects were placed sequentially into three different dose groups, 5.0×107 cells/time (low-dose group), 1.5×108 cells/time (medium-dose group), and 5.0×108 cells/time (high-dose group) for dose escalation
Anhui province hospital
Hefei, Anhui, China
DLT,MTD
Dose-limiting toxicity(DLT): frequency of occurrence, level of dose of DLT toxicity;Maximum tolerated dose (MTD)
Time frame: 28 days
fibrosis staging and inflammatory grading
Histological changes in liver biopsy at day 180 after cell therapy.Methods: A small amount of liver tissue was taken from the liver by percutaneous puncture, and its histological changes were observed directly under the microscope. According to the pathological results, the Ishak scoring system for liver fibrosis (which includes fibrosis stage and inflammation grade evaluation criteria) was used to evaluate liver fibrosis, in which 0 was the best and 6 was the worst.
Time frame: 180 days
All-cause mortality
the ratio of the total number of deaths due to various factors over 1 year of cell therapy to the number of people in this population for the same period
Time frame: 1 year
TE(Transient elastography)
Changes in transient elastography.Methods: A special probe was used to generate an instantaneous low-frequency pulse to cause instantaneous displacement and shear wave in the liver tissue. The shear wave was tracked and collected to obtain the elastic modulus of the tissue, and the degree of liver fibrosis was evaluated by liver stiffness measurement (LSM). The higher the shear wave velocity, the higher the LSM value, and the stiffer the liver tissue in the detection area.
Time frame: 1 year
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