Benzinga | Jun 22, 2021 08:04AM EDT

Caladrius Biosciences Says To Assess Its CLBS201 CD34+ Cell Therapy In Diabetic Kidney Disease

Caladrius Biosciences, Inc. (NASDAQ:CLBS) ("Caladrius" or the "Company"), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease, today announced that the U.S. Food and Drug Administration ("FDA") has authorized its investigational new drug ("IND") application for the study of CLBS201, a CD34+ cell therapy for the treatment of diabetic kidney disease ("DKD").



"Our latest development program, CLBS201, is designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for diabetic patients with reduced kidney function. Specifically, we will be targeting patients with later stage chronic kidney disease. Based on a wealth of published preclinical and early clinical data, it appears that the innate ability of CD34+ cells to promote the growth of new microvasculature could be a means to attenuate the progression, or even reverse the course, of DKD," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. "We plan to initiate a phase 1/2 proof-of-concept study of CLBS201 within the next several months. Kidney disease remains a largely unmet medical need, especially as the general population ages and the incidence of diabetes and hypertension increases."