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Caladrius Biosciences, Inc. (NASDAQ:CLBS) ("Caladrius" or the "Company"), a clinical-stage biopharmaceutical company developing innovative therapies designed to treat or reverse disease, announced today the completion of enrollment and dosing in its Phase 1b, open-label, proof-of-concept study of CLBS201, a CD34+ regenerative cell therapy investigational product for intra-renal artery administration, for the treatment of diabetic kidney disease ("DKD"). The Company expects to announce top-line data from all subjects by the first quarter of 2023.
"We are pleased to announce that we have treated the last subject in our Phase 1b clinical trial evaluating CLBS201, which focuses on individuals who exhibit rapidly progressing stage 3b/4 DKD," stated Kristen K. Buck, M.D., Executive Vice President of R&D and Chief Medical Officer of Caladrius. "We look forward to sharing top-line data after all subjects have completed their six-month follow-up visit."
"Intra-renal artery infusion of CD34+ cells could be a breakthrough in the treatment of diabetic kidney disease; we are excited about our work with Caladrius on this program," stated Dr. Pablo Pergola, Research Director, Renal Associates, P.A., San Antonio, Texas, and principal investigator for the study. "We look forward to reviewing the results of this study and the potential development of a treatment for patients in need."
About the Phase 1b clinical trial of CLBS201 for the treatment of DKD
Progressive kidney failure is associated with attrition of the microcirculation of the kidney. Preclinical studies in kidney disease and injury models have demonstrated that protection or replenishment of the microcirculation results in improved kidney function. Based on these observations, the Company recently initiated a Phase 1, open-label, proof-of-concept trial evaluating CLBS201, a CD34+ regenerative cell therapy investigational product for intra-renal artery administration in patients with DKD. Patients selected for the study were in the pre-dialysis stage of kidney disease and exhibited rapidly progressing stage 3b disease. The objective of the protocol is to evaluate the tolerance of intra-renal cell therapy injection in DKD patients as well as the ability of CLBS201 to regenerate kidney function. For more information on this study, please visit clinicaltrials.gov (identifier: NCT04990427).
About Diabetic Kidney Disease
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.
Posted In: CLBS
