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 |
| Link |
http://purl.obolibrary.org/obo/NCIT_C95802 |
| Description |
An acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of brain tissue. |
|
Administrative Information |
| NCT number |
NCT06138210 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06138210 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/ct2/show/NCT06138210 |
| Public contact |
| Email |
haojunwei@vip.163.com |
| Public email |
haojunwei@vip.163.com |
| First name |
Junwei |
| Last name |
Hao |
| Phone |
+86 10 8319 8277 |
| Country |
|
|
| Sponsors |
Xuanwu Hospital, Beijing
|
| Collaborators |
|
Cells |
Recruitment |
| Recruitment Status |
Recruiting |
| Estimated number of participants |
29 |
