Caladrius Biosciences Treats First Patient in the Phase 1b Trial for the Treatment of Diabetic Kidney Disease

Caladrius Biosciences, Inc. recently announced the first patient has been treated in its Phase 1b open-label, proof-of-concept study of CLBS201 for the treatment of diabetic kidney disease (DKD) at the Clinical Advancement Center in San Antonio, Texas. CLBS201 is an investigational autologous CD34+ cell therapy product for administration directly into the renal artery(ies) to reverse or slow the decline of renal function in diabetic patients with rapidly progressive chronic kidney disease (CKD).

“With this trial, we hope to bring much improved patient outcomes to diabetic patients with reduced kidney function. Specifically, we are targeting patients with later stage CKD. Based on a wealth of published preclinical and early clinical data, we believe that the innate ability of CD34+ cells to promote the growth of new microvasculature could be a means to attenuate the progression or, potentially, reverse the course of DKD,” said David J. Mazzo, PhD, President and Chief Executive Officer of Caladrius. “The treatment of the first patient in this Phase 1b study of CLBS201 is another important milestone for our company and we anticipate top-line data by the first quarter of 2023.”

“Regenerative medicine is a new, but rapidly evolving strategy for treating diabetic kidney disease and shows much promise as a potential breakthrough,” stated Dr. Pablo Pergola, Research Director, Renal Associates, PA, San Antonio, TX, and principal investigator for the study. “My practice is proud and excited to be at the forefront of this effort.”

For more information on this study, please visit clinicaltrials.gov (identifier: NCT04990427).

DKD, also called diabetic nephropathy, is a serious kidney-related complication of diabetes. Diabetes mellitus is the leading cause of kidney disease; approximately 40% of individuals with diabetes have DKD. Over time, high blood sugar from poorly controlled diabetes can damage the small blood vessels (microvasculature) in the kidneys, which can lead to kidney damage. This microvascular complication may eventually develop in approximately 30% of patients with type 1 diabetes and approximately 40% of patients with type 2 diabetes. All-cause mortality in patients with DKD is reported to be higher than in patients with diabetes without kidney disease.

Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of innovative therapies designed to treat or reverse disease. We currently are developing first-in-class autologous cell therapy products based on the finely tuned mechanisms for self-repair that exist in the human body. Our technology leverages and enables these mechanisms in the form of specific cells, using formulations and modes of delivery unique to each medical indication.

The company’s current product candidates include: XOWNA (CLBS16), the subject of both a recently completed positive Phase 2a study and an ongoing Phase 2b study (www.freedom-trial.com) in the US for the treatment of coronary microvascular dysfunction (CMD); CLBS12 (HONEDRA in Japan), recipient of a SAKIGAKE designation in Japan and eligible for early conditional approval for the treatment of critical limb ischemia (CLI) and Buerger’s disease based on the results of an ongoing clinical trial; and CLBS201, designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for diabetic kidney disease (DKD). For more information, visit www.caladrius.com.