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US 2026/0287576 A1Published application
Potency assay matrix for neuronal cells
AssigneeAspen Neuroscience, Inc.
InventorsDaniel Fremgen, Candace Lynch
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AssigneeAspen Neuroscience, Inc.
InventorsDaniel Fremgen, Candace Lynch
Estimating the term…
The invention provides, in some embodiments, a potency assay matrix for assessing potency of dopaminergic neuronal progenitor cells (DANPCs) that are intended for use in treating a neurodegenerative disease such as Parkinson's Disease. The potency assay matrix can include a bioassay for L-DOPA decarboxylase (DDC) activity. In addition to the DDC activity assay matrix, the potency assay matrix may also include one or more additional mechanism of action-based assays such as bioinformatics-based assays for determining whether the DANPCs are dopaminergic neuronal progenitor cells, for determining whether the DANPCs are likely to engraft when implanted into a subject brain, and for determining whether neuronal cells that are derived from the DANPCs are likely to produce dopamine after implantation.
A method of assessing potency of a population of neuronal progenitor cells intended for implantation into a subject in need of treatment for a neurodegenerative disease, the method comprising:
A method of preparing a pharmaceutical composition for implantation into a subject in need of treatment for a neurodegenerative disease, the method comprising:
A method of obtaining a composition that comprises dopaminergic neuronal progenitor cells, the method comprising:
A method of determining potency of a pharmaceutical composition comprising neuronal progenitor cells intended for treating a neurodegenerative disease, the method comprising determining an activity level of L-dihydroxyphenylalanine (DOPA) decarboxylase (DDC) in a sample obtained from the pharmaceutical composition, wherein an increased activity level of DDC in the sample compared to a reference DDC activity level is predictive of dopamine production by neuronal cells derived from the neuronal progenitor cells in the pharmaceutical composition.
Dependencies are inferred from the claim text.