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Obnitix (MC0518, MSC-FFM) is an allogeneic somatic cell therapy consisting of ex-vivo expanded human bone marrow-derived mesenchymal stromal cells (MSCs). Developed by medac in collaboration with Goethe University Frankfurt and the German Red Cross Blood Service Baden-Württemberg-Hessen, Obnitix is manufactured using a standardized process that pools mononuclear bone marrow cells from eight healthy, HLA-disparate donors to minimize batch-to-batch variability and enhance immunomodulatory potency. The therapy exerts its therapeutic effects through immunomodulation and tissue repair, primarily by inhibiting T- and B-lymphocyte proliferation, reducing dendritic cell activation, and stimulating regulatory T cells via soluble mediators (such as TGF-beta, indoleamine 2,3-dioxygenase, and prostaglandin E2) and direct cell-cell contact. Obnitix is primarily developed for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) following allogeneic hematopoietic stem cell transplantation.
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