The United States Food and Drug Administration (FDA) has granted Osiris Therapeutics fast-track status for their agent Prochymal™ as initial therapy for acute graft-versus-host-disease (GVHD).
Prochymal is a preparation of mesenchymal stem cells that are infused intravenously. It appears that the stem cells alter cytokine secretion by dendritic T-cell subsets, resulting in anti-inflammatory actions, and ultimately halting the pro-inflammatory process of GVHD. In addition, the mesenchymal stem cells appear to provide long-term effects in repair of damaged tissue.
Prochymal has also been granted orphan drug status for GVHD.
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