General Information |
Summary |
The DOSED clinical study evaluates the safety and utility of a novel delivery device to deliver LCTOPC1, a cell therapy, to the spinal cord of patients with a spinal cord injury (SCI). LCTOPC1 is designed to replace or support cells that are absent or dysfunctional due to traumatic injury, with a goal to help improve the quality of life and restore or augment functional activity in persons suffering from a traumatic cervical or thoracic injuries. |
Description |
LCTOPC1-SCI-03 DOSED study is a Phase 1b, open-label, multi-center, device safety study designed to assess the safety of a novel delivery device for administering a one-time injection of LCTOPC1. The study will enroll 3-5 participants with subacute (21 to 42 days post-injury) spinal cord injuries and 3-5 participants with chronic (1 to 5 years post-injury) spinal cord injuries. Eligible participants must have either sensorimotor complete (AIS-A) or motor complete / sensory incomplete spinal cord injuries (AIS-B), located in the cervical (C4-C7) or thoracic (T1-T10) regions. The first four patients will be enrolled sequentially subsequent to meeting safety requirements. Participants will be monitored for long-term safety for up to 10 years following the administration of LCTOPC1. |
Clinical trials phase |
Phase 1 |
Start date (estimated) |
2025-04-30 |
End date (estimated) |
2037-04-27 |
Clinical feature |
Label |
spinal cord disease |
Link |
http://purl.obolibrary.org/obo/DOID_319 |
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Administrative Information |
NCT number |
NCT06841770 |
ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06841770 |
Other study identifiers |
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Source weblink |
https://clinicaltrials.gov/study/NCT06841770 |
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 |
Not yet recruiting |
Estimated number of participants |
10 |