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 |
| Public contact |
| Email |
info@biotimeinc.com |
| Public email |
info@biotimeinc.com |
|
| 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 progenitor cell of the central nervous system that can differentiate into oligodendrocytes or type-2 astrocytes. This cell originates from multiple structures within the developing brain including the medial ganglion eminence and the lateral ganglionic eminence. These cells migrate throughout the central nervous system and persist into adulthood where they play an important role in remyelination of injured neurons.; 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). |
|
Recruitment |
| Recruitment Status |
Completed |
| Estimated number of participants |
25 |
