Abstract: The present disclosure provides methods for selecting a patient diagnosed with amyotrophic lateral sclerosis (ALS) for an ALS therapy, methods for assessing a ALS patient's likely responsiveness to an ALS therapy, methods for treating an ALS patient with an ALS therapy, methods for monitoring efficacy of an ALS therapy, and methods for assessing the likely progression of ALS in a patient, in which methods serum concentrations of one or more serum immune-based biomarkers are determined.

Abstract: Disclosed are improved, bioreactor-based methods for manufacturing large-scale populations of robust, highly pure, and functional T regulatory cells (Tregs). Also disclosed are expanded Treg populations, cryopreserved Treg populations and methods and uses of these cells in compositions formulated for treating one or more mammalian diseases, including, for example, treatment, prophylaxis, and/or amelioration of one or more symptoms of a human neurodegenerative disorder. In particular, the compositions and methods provided herein find clinical use in the treatment and amelioration of one or more symptoms of amyotrophic lateral sclerosis (ALS), Alzheimer's disease, and other neurological diseases and disorders.

Abstract: The present disclosure provides methods for treating diseases such as neurodegenerative and neuroinflammatory diseases, for example, Alzheimer's disease, comprising administration of a CTLA-4-containing protein, e.g., abatacept, and an IL-2 protein, e.g., aldesleukin, to a subject, either separately or in a single formulation. Also presented herein are pharmaceutical compositions comprising a CTLA-4-containing protein, e.g., abatacept, and an IL-2 protein, e.g., aldesleukin.