Caladrius Biosciences

Associate Sponsor

Caladrius is a clinical-stage biopharmaceutical company committed to the development of innovative products in cardiovascular and autoimmune disease that have the potential to restore the health of people with chronic illnesses. Our leadership team collectively has decades of drug development experience and globally-recognized scientific achievement. Our goal is to build a broad portfolio of novel and versatile products that address important unmet medical needs.Caladrius currently has four programs in the mid to late stages of clinical development. Our product candidates include three cell therapies for cardiovascular diseases that are based on our autologous CD34+ cell therapy platform: CLBS12, in Phase 2 testing in Japan, recipient of SAKIGAKE designation (similar to breakthrough designation in the USA), and eligible for early conditional approval for the treatment of critical limb ischemia; CLBS16, in Phase 2 testing for the treatment of coronary microvascular dysfunction; and CLBS14, in late-stage development for no-option refractory disabling angina (NORDA) and a recipient of Regenerative Medicine Advanced Therapy designation (essentially, breakthrough designation for cell and gene therapies) from the FDA. In addition, Caladrius has an autoimmune product candidate, CLBS03, in Phase 2 testing. CLBS03 is an autologous  ex vivo  expanded and activated polyclonal T regulatory cell therapy for the treatment of recent-onset type 1 diabetes. CLBS03 has been awarded Fast Track and Orphan designations by the FDA and Advanced Therapeutic Medicine Product classification by the EMA.We are developing new products to treat those in need and are dedicated to enabling people to enjoy healthier, longer, and more productive lives.

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