A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of Intravenous UMC119-06 in Patients with Acute Ischemic Stroke.

ABSTRACT: This first-in-human, open-label, dose-escalation study (NCT04097652) evaluates UMC119-06, a mesenchymal stem cell product derived from human umbilical cord, for the treatment of acute ischemic stroke (AIS). The study includes two dosing cohorts: 1×10^6 cells/kg and 5×10^6 cells/kg, with three participants enrolled in each cohort. The primary objective is to assess the safety, tolerability, and maximum feasible dose of UMC119-06 in AIS patients, while the secondary objective focuses on evaluating long-term safety and clinical efficacy following a single administration. The study conducted safety assessments across both dosing cohorts, demonstrating that UMC119-06 is well-tolerated, with no adverse events (AEs) classified as possibly, probably, or definitely related to the product. Despite t

SUBMITTER: Chan L 

PROVIDER: S-EPMC12825123 | biostudies-literature | 2026

REPOSITORIES: biostudies-literature