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Caladrius Biosciences (CLBS) Suspends Patient Enrollment in Phase 2b FREEDOM Trial of XOWNA

Caladrius Biosciences (CLBS) Suspends Patient Enrollment in Phase 2b FREEDOM Trial of XOWNA
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Caladrius Biosciences (CLBS) to Merge with Cend Therapeutics

Caladrius Biosciences (CLBS) to Merge with Cend Therapeutics
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FDA grants orphan drug designation to cell therapy for Buerger's disease


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The FDA granted orphan drug designation to CLBS12, an investigational nongene-edited cell therapy for the treatment of Buerger’s disease, according to the agent’s manufacturer.
Buerger’s disease, also known as thromboangiitis obliterans, is a condition related to critical limb ischemia and has no approved treatments in the United States.
Source: Adobe Stock.
CLBS12 (Honedra, Caladrius Biosciences) is an autologous cell therapy derived from CD34+ cells. Patients who receive the therapy undergo apheresis that includes drug-induced mobilization of CD34+ cells from bone marrow. The cells are subsequently isolated, concentrated and administered as an IV infusion. ....

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