General Information |
| Summary |
The purpose of this study is to evaluate the safety of cross sequential escalating doses of AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI). |
| Clinical trials phase |
Phases 1/2 |
| Start date (estimated) |
2015-03-01 |
| End date (estimated) |
2018-12-31 |
| Clinical feature |
| Label |
Spinal cord injury |
| Link |
http://www.orpha.net/ORDO/Orphanet_90058 |
|
| Publications |
|
Administrative Information |
| NCT number |
NCT02302157 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT02302157 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/ct2/show/NCT02302157 |
| Sponsors |
Asterias Biotherapeutics, Inc
|
Cells |
| Source pluripotent stem cell lines |
|
| Which differentiated cell type is used |
| Label |
oligodendrocyte precursor cell |
| Link |
http://purl.obolibrary.org/obo/CL_0002453 |
| Description |
A proliferative and migratory glial progenitor cell that derives from a neural stem cell and resides within the central nervous system. It possesses the capacity to differentiate into a committed oligodendrocyte progenitor (COP) through a well-defined series of maturation steps, ultimately giving rise to a myelinating oligodendrocyte (MOL). In mice and humans, it is characterized by the expression of specific molecular markers, including Pdgfra, Cspg4 (also known as NG2) and Olig2.; This cell type can be purified from optic nerves and other regions of the embryonic, postnatal and adult rat CNS and can be differentiated in vitro to oligodendrocytes and type-2 astrocytes. Some references use the terms 'oligodendrocyte precursor cell' and 'oligodendrocyte type-2 astrocyte (O-2A) progenitor' to refer to the same entity (e.g., PMID:10704434), while others describe an oligodendrocyte type-2 astrocyte (O-2A) progenitor cell as the precurosr to oligodendrocyte- and type-2 astrocyte- progenitor cells (e.g, ISBN:9780702028991). |
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Recruitment |
| Recruitment Status |
Completed |
| Estimated number of participants |
25 |
