Autoimmune diseases cost the U.S. more than $100 million annually. Immune tolerance happens, among other things, from the suppression of self-reactive T effector cells and auto-antigen presenting cells by T-regulatory (Treg) cells. A deficit of T-regulatory cells can lead to serious allergic and autoimmune diseases, such as Type 1 diabetes mellitus (T1DM). Caladrius Biosciences (NASDAQ: CLBS) uses T Regulatory Cell Technology to increase autologous T-regulatory cells and function, representing the potential for “true disease modification.” The company is developing a therapy based on this technology (CLBS03) for the treatment of T1DM. After announcing positive results for a phase 1 study for the treatment of T1DM, the company launched its phase 2 therapeutic study, a randomized, double-blind, placebo controlled trial in patients aged 12 to 17 with recent onset of T1DM. CLBS03 has received Fast Track and Orphan Drug designations from the FDA as well as Advanced Therapeutic Medicinal Product (ATMP) classification from the European Medicines Agency.
To learn more visit www.caladrius.com
About Caladrius Biosciences, Inc.
Caladrius Biosciences, Inc. is a cell therapy development company with cell therapy products in development based on multiple technology platforms and targeting autoimmune and cardiology indications. The company’s subsidiary, PCT, is a leading development and manufacturing partner exclusively focused on the cell therapy industry and has served over 100 clients since 1999. PCT provides a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support.
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