General Information |
| Summary |
A Phase 1 Dose-escalation, Single-Center, Open-labeled Study to Evaluate the Safety and Tolerability of Human Induced Pluripotent Stem Cell-derived Human Forebrain Neural Progenitor Cell Injection (hNPC01) in Chronic Ischemic Stroke. |
| Description |
The primary aims of this open-label single-armed study is to evaluate the safety and tolerability up to 4 cohorts of escalating doses of hNPC01 administered at a single dose via intracerebral injection to subjects with chronic cerebral ischemic stroke, and to determine MTD. The exploratory aim is to explore the evaluation tools with preliminary efficacy assessment and the potential of hNPC01 to mitigate the symptoms, especially motor symptoms associated with chronic stroke. Eligible participants for this study are individuals who have experienced a single ischemic stroke 6 to 60 months prior of enrollment and have exhibited no significant improvement following standard physical therapy interventions. |
| Clinical trials phase |
Phase 1 |
| Start date (estimated) |
2023-11-09 |
| End date (estimated) |
2025-12-30 |
| 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 |
NCT06299033 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06299033 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/study/NCT06299033 |
| Public contact |
| Email |
shuningzh@hopstem.com |
| Public email |
shuningzh@hopstem.com |
| First name |
Shuning |
| Last name |
Zhang |
| Phone |
+86 571-88197776 |
| Country |
|
|
| Sponsors |
Hopstem Biotechnology Inc.
|
Cells |
| Which differentiated cell type is used |
| Label |
neural stem cell |
| Link |
http://purl.obolibrary.org/obo/CL_0000047 |
| Description |
An undifferentiated neural cell that originates from the neuroectoderm and has the capacity both to perpetually self-renew without differentiating and to generate multiple central nervous system neuronal and glial cell types. |
|
Recruitment |
| Recruitment Status |
Recruiting |
| Estimated number of participants |
21 |
