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 |
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| Source weblink |
https://clinicaltrials.gov/ct2/show/study/NCT01217008 |
| Regulatory body approval |
| Name |
Food and Drug Administration (FDA) |
| Country |
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| Public contact |
| Email |
MedicalInquiries@asteriasbio.com |
| 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 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). |
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Recruitment |
| Recruitment Status |
Completed |
| Estimated number of participants |
5 |
