Cell therapies and methods of treatment for small-volume stroke
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Publication Number
US-12121544-B2
Publication Date
2024-10-22
Expiration Date
Abstract
Disclosed are methods of treating a subject following a small-volume ischemic stroke suffered by the subject and methods of treating a subject with a stroke-induced motor deficit. Disclosed also is a composition for treating small-volume ischemic stroke. In one aspect, the method of treating a subject following a small-volume ischemic stroke comprises administering, to a brain region surrounding a small-volume ischemic core of the subject, a therapeutically effective amount of cells, wherein the cells are descended from mesenchymal stem cells transiently-transfected by a polynucleotide encoding a Notch intracellular domain.
Core Innovation
The document describes regenerative cell therapy for a subject with a stroke-induced motor deficit by using vandefitemcel cells. The therapy includes determining a volume of an ischemic core of the subject and administering a therapeutically effective amount of the cells to a brain region surrounding the ischemic core, including ischemic penumbra. Administration is limited to cases in which the determined ischemic core volume is less than 50 cubic centimeters (cc).
The cells used are vandefitemcel, which are cells descended from mesenchymal stem cells transiently-transfected by a polynucleotide encoding a Notch intracellular domain (NICD). The NICD polynucleotide does not encode full-length Notch protein, and the cell population is therefore derived from mesenchymal stem cells with transient NICD transfection. The administered cells are described as a cell suspension formulated in a sterile isotonic crystalloid and provided in a sealed vial.
The document further describes that eligibility may be based on disability using an mRS score between 2 and 4, and eligibility is defined using imaging modalities to assess ischemic core volume. Clinical trial analysis reported in the document shows statistically significant improvements for a small-volume stroke subpopulation defined by ischemic core volume less than 50 cc.
Claims Coverage
The document contains one independent claim, describing a method of treating a subject with a stroke-induced motor deficit using vandefitemcel cells, with administration restricted by an ischemic core volume threshold of less than 50 cubic centimeters (cc).
Ischemic core volume determination and <50 cc-only administration
Determining a volume of an ischemic core of the subject and administering, to a brain region surrounding the ischemic core of the subject, a therapeutically effective amount of cells only when the volume of the ischemic core is determined to be less than 50 cubic centimeters (cc).
Use of vandefitemcel derived from transient NICD polynucleotide transfection
Using cells that are vandefitemcel, wherein the cells are cells descended from mesenchymal stem cells transiently-transfected by a polynucleotide encoding a Notch intracellular domain (NICD).
Overall claim coverage centers on treating stroke-induced motor deficit with vandefitemcel cells, where administration is conditioned on ischemic core volume being less than 50 cc, and the therapeutic cells are derived from transient NICD polynucleotide-transfected mesenchymal stem cells.
Stated Advantages
Statistically significant improvements are reported for a small-volume stroke subpopulation defined by ischemic core volume <50 cc compared with sham/control.
Additional location-dependent findings are reported, including a better response when stroke is not in cortical parietal region.
Documented Applications
Treating a subject with a stroke-induced motor deficit using regenerative cell therapy with vandefitemcel cells, with administration to brain tissue surrounding the ischemic core/ischemic penumbra and eligibility based on ischemic core volume <50 cc.
Clinical trial and sham/control comparison in a randomized double-blind trial context for small-volume ischemic stroke subpopulations and related retrospective analyses.
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