General Information |
| Summary |
The purpose of the study is to evaluate the safety of GRNOPC1 administered at a single time-point between 7 and 14 days post injury, inclusive, to patients with neurologically complete spinal cord injuries (SCI). |
| Description |
Not Provided |
| Clinical trials phase |
Phase 1 |
| Start date (estimated) |
2010-10-01 |
| End date (estimated) |
2013-07-31 |
| Clinical feature |
| Label |
Spinal cord injury |
| Link |
http://www.orpha.net/ORDO/Orphanet_90058 |
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| Publications |
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Administrative Information |
| NCT number |
NCT01217008 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT01217008 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/ct2/show/study/NCT01217008 |
| Regulatory body approval |
| Name |
Food and Drug Administration (FDA) |
| Country |
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| Sponsors |
Lineage Cell Therapeutics, Inc.
|
Cells |
| Source pluripotent stem cell lines |
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| 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 |
5 |
