General Information |
| Summary |
Evaluation of the safety and tolerability of escalating doses of NR1 administered intracerebrally at a single time-point post-injury to subjects with chronic ISS with or without cortical stroke. |
| Description |
Evaluation of the safety and tolerability of escalating doses of NR1 administered intracerebrally at a single time-point post-injury to subjects with chronic ISS with or without cortical stroke. The study will be a dose escalation using up to 4 cohorts each at a single dose level, of intracerebral administration of NR1 cells. Secondary objectives are to evaluate clinical and radiologic responses as well as utility of efficacy measurement tools. |
| Clinical trials phase |
Phases 1/2 |
| Start date (estimated) |
2021-01-04 |
| End date (estimated) |
2025-05-31 |
| 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 |
NCT04631406 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04631406 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/ct2/show/NCT04631406 |
| Sponsors |
Gary Steinberg
|
| Collaborators |
|
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 |
30 |
| Contact institutions/departments |
|
