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 |
|
Administrative Information |
| NCT number |
NCT06841770 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06841770 |
| Other study identifiers |
|
| 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 |
|
| 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.; An oligodendrocyte precursor cell (OPC), also commonly referred to as an oligodendrocyte progenitor cell, is an undifferentiated or immature type of cell found in the nervous system that differentiates into a fully mature oligodendrocyte. Oligodendrocytes are known for their role in creating the protective myelin sheath that covers and insulates neurons in the central nervous system, enhancing the speed and efficiency of neurological signal transmission. OPCs contribute to this vital process by providing a consistent source of new oligodendrocytes.
OPCs are unique for their remarkable flexibility and adaptability, making them a critical element in many neurological processes. They are involved in neurogenesis and reparative functions as they can proliferate and be mobilized to areas of brain injury to aid in tissue repair and regeneration. Particularly, they play a significant role in the recovery and remyelination of damaged neurons, attributing to their prolific distribution in both gray and white matter areas of the brain and spinal cord.
Recent research has revealed the broader plasticity of OPCs. Studies have shown that OPCs can also differentiate into astrocytes and neurons under certain conditions, enlarging their role from just players in myelination to contributors in maintaining the integrity and adaptability of the central nervous system. Furthermore, these cells have been found to interact directly with neurons and take part in synaptic transmission, implying a more complex role in neural network activity.
(This extended description was generated by ChatGPT and reviewed by the CellGuide team, who added references, and by the CL editors, who approved it for inclusion in CL. It may contain information that applies only to some subtypes and species, and so should not be considered definitional.); 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 |
