Abstract: The present disclosure provides methods for treating ALS using pentostatin and cyclophosphamide treatment followed by TREG and/or TREG/Th2 hybrid cells from de-differentiated T cells. The present disclosure further provides methods for producing TREG and TREG/Th2 hybrid cells from de-differentiated T cells, said TREG and TREG/Th2 hybrid cells, populations thereof and compositions thereof. Methods for producing de-differentiated T cells, said de-differentiated T cells, populations thereof and compositions thereof are also provided.

Abstract: T cells harvested from an ALS patient are subjected to a de-differentiation and re-differentiation process to yield TREG/Th2 hybrid T cells and are then administered to the ALS patient as a cell therapy. The harvested T cells are first cultured in medium containing vitamin D, temsirolimus, and an IL-2 signaling inhibitor to de-differentiate the cells and then the de-differentiated cells are then transferred to a culture medium with IL-2, IL-4, and TGF-?.

Abstract: The present disclosure provides methods for treating pro-inflammatory diseases and conditions, optionally using pentostatin and cyclophosphamide pre-treatment, by administration of TREG and/or TREG/Th2 hybrid cells from de-differentiated T cells. The source of T cells can be autologous (from the affected subject) or allogenic (off-the-shelf bank of therapeutic cells; generated from healthy unrelated volunteers). The present disclosure further provides methods for producing TREG and TREG/Th2 hybrid cells from de-differentiated T cells, said TREG and TREG/Th2 hybrid cells, populations thereof and compositions thereof. Methods for producing de-differentiated T cells, said de-differentiated T cells, populations thereof and compositions thereof are also provided.

Abstract: The present disclosure provides methods for treating cancer and infectious disease using manufactured T cells or other cell types including antigen-presenting T cells, loaded, antigen-presenting T cells, sensitized, manufactured T cells and combinations thereof which can be co-administered with the manufactured T cells or without. Methods of treatment can include administration of pentostatin and cyclophosphamide followed by administration of T cells. The present disclosure also provides methods to produce antigen-presenting T cells from the manufactured T cells, load said antigen-presenting T cells and to sensitize the manufactured T cells using the loaded, antigen-presenting T cells. Methods of treatment using the antigen-presenting T cells and/or sensitized, manufactured T cells are also provided which can be performed in vivo or ex vivo.

Abstract: The present disclosure provides methods for treating ALS using pentostatin and cyclophosphamide treatment followed by TREG and/or TREG/Th2 hybrid cells from de-differentiated T cells. The present disclosure further provides methods for producing TREG and TREG/Th2 hybrid cells from de-differentiated T cells, said TREG and TREG/Th2 hybrid cells, populations thereof and compositions thereof. Methods for producing de-differentiated T cells, said de-differentiated T cells, populations thereof and compositions thereof are also provided.

Abstract: The present disclosure provides methods for treating cancer. Methods for treating cancer can include administration of pentostatin and cyclophosphamide followed by administration of manufactured T cells. The present disclosure further provides for methods for producing such manufactured T cells, said manufactured T cells and compositions comprising said manufactured T cells.

Abstract: The present disclosure provides methods for monitoring inflammation in ALS and other related diseases. Therapeutic interventions based on the results of monitoring methods are also provided.