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Clinical Trial Summary

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


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT06296095
Study type Interventional
Source Anhui Provincial Hospital
Contact
Status Enrolling by invitation
Phase Phase 1
Start date August 9, 2023
Completion date December 31, 2024

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