The Effect of GD-iExo-003 in Acute Ischemic Stroke ExoCURE

General Information

Summary This is a multicenter, randomized, double-blinded, placebo-controlled, dose-escalation trial. The objective of this study is evaluating safety and preliminary efficacy of intravenous exosomes derived from human induced pluripotent stem cell (GD-iExo-003) in acute ischemic stroke.
Description This is a multicenter, randomized, double-blinded, placebo-controlled, dose-escalation trial. This study will consist of 2 parts, with part 1 being a dose-escalation study and part 2 being an expanded safety study based on part 1 findings. A traditional 3+3 dose escalation design will be implemented in part 1. Cohort 1 receive 20μg/kg; cohort 2 40μg/kg and cohort 3 80μg/kg. If no dose-limiting toxicities (DLTs) are observed for 2 weeks after administration of the first injection, a new cohort will be enrolled at the next planned dose level. If DLTs are observed in 1 participant in the cohort, another 3 participants will be treated in the same dose level. Dose escalation will be stopped until DLTs are observed in >33% of the participants. In part 2, 20 subjects will be randomized in a 1:1 ratio [exosome (n=10) or exosome placebo (n=10)]. The dose level will be determined by Data Safety Monitoring Board based on part 1.
Clinical trials phase Phase 1
Start date (estimated) 2024-05-27
End date (estimated) 2025-08-30
Clinical feature
Label Ischemic Stroke
Description An acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of brain tissue.

Administrative Information

NCT number NCT06138210
ICTRP weblink
Other study identifiers
Name XMEC-2023-004
Source weblink
Public contact
Public email
First name Junwei
Last name Hao
Phone +86 10 8319 8277
Sponsors Xuanwu Hospital, Beijing



Recruitment Status Recruiting
Estimated number of participants 29