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FCRx is an investigational allogeneic cell therapy platform developed by Talaris Therapeutics (formerly Regenerex). The therapy consists of a proprietary cell product containing CD34+ hematopoietic stem cells (HSCs), facilitating cells (CD8+/TCR-), and αβ T cells derived from a healthy donor. The unique "facilitating cells" are designed to promote stable engraftment of donor HSCs in the recipient's bone marrow without the need for full myeloablative conditioning or the high risk of graft-versus-host disease (GvHD). In the context of Metachromatic Leukodystrophy (MLD), the goal of FCRx is to establish donor-derived hematopoiesis to provide a continuous source of functional arylsulfatase A (ARSA) enzyme. This enzyme replacement, mediated by the engrafted donor cells, is intended to slow or halt the neurodegeneration associated with MLD. Talaris Therapeutics discontinued its cell therapy programs in 2023 following a strategic review and subsequent merger.
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