Safety Study of GRNOPC1 in Spinal Cord Injury

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
Publications

Administrative Information

NCT number NCT01217008
ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=NCT01217008
Other study identifiers
Name CP35A007
Source weblink https://clinicaltrials.gov/ct2/show/study/NCT01217008
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.; 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).

Recruitment

Recruitment Status Completed
Estimated number of participants 5