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Obnitix (medac GmbH)

Development stage: Unknown
Lead developer: medac
Modality: Stem Cell Therapies → Cell Therapies
Administration: Intravenous

Overview

Obnitix (MC0518 / MSC-FFM) is an allogeneic, bone marrow-derived mesenchymal stromal cell (MSC) therapy developed by medac in collaboration with Goethe University Frankfurt and the German Red Cross Blood Service Baden-Württemberg Hessen. It 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. Obnitix is primarily developed for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric and adult patients following allogeneic hematopoietic stem cell transplantation. It is also being investigated for other inflammatory conditions, such as COVID-19-associated acute respiratory distress syndrome (ARDS). Obnitix is currently available in Germany under a hospital exemption and is undergoing Phase III clinical evaluation.

Brand names: Obnitix
Other names: Obnitix MSCshuman allogeneic bone marrow derived mesenchymal stromal cells, ex-vivo expanded

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