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A Study to Evaluate the Safety of a Delivery Device for Administering LCTOPC1 in Participants with Spinal Cord Injury (DOSED)

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
Name LCTOPC1-SCI-03
Source weblink https://clinicaltrials.gov/study/NCT06841770
Regulatory body approval
Name Food and Drug Administration (FDA)
Country
United States
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.; 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 Not yet recruiting
Estimated number of participants 10