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CLBS03 is a personalized autologous cell therapy composed of each patient's own regulatory T cells (Tregs), which are expanded in number and functionally enhanced ex vivo using a proprietary method. The therapeutic rationale is to restore immune balance in autoimmune diseases by increasing the number and activity of functional Tregs, thereby suppressing autoreactive effector T cells that attack self-tissues. In type 1 diabetes mellitus (T1D), this approach aims to protect insulin-producing pancreatic beta cells from immune-mediated destruction. CLBS03 has received FDA Fast Track designation and Orphan Drug status for recent-onset type 1 diabetes with residual beta cell function. The product was developed through collaborations involving Caladrius Biosciences (now Lisata Therapeutics), Becton, Dickinson and Company, Sanford Health, University of California at San Francisco, and Athelos Corporation[1][2][4][5][6][7].
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