Diabetic Kidney Disease (DKD) - CLBS201
What is Chronic Kidney Disease (CKD)?
Chronic kidney disease (CKD), also called chronic kidney failure, is a growing health problem. CKD is the gradual loss of kidney function. Kidneys filter wastes and excess fluids from the blood, which are then excreted in urine. When chronic kidney disease reaches an advanced stage, dangerous levels of fluid, electrolytes and wastes can build up in the body.
What is Diabetic Kidney Disease (DKD)?
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. (1) 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. (2) (3)
DKD represents a large unmet medical need
The increasing prevalence of DKD parallels the dramatic worldwide rise in the prevalence of diabetes. In the United States, the prevalence of diabetes among adults increased from 9.8% in the 1988–1994 time period to 12.3% in the 2011–2012 time period. (4) Worldwide, in the year 2015, 415 million people were estimated to have diabetes; by 2040, prevalence is projected to increase to 642 million. (5)
CKD attributed to diabetes is a major but under-recognized contributor to the global burden of disease. Between 1990 and 2012, the number of deaths attributed to DKD rose by 94%. (6) This dramatic rise is one of the highest observed for all reported chronic diseases. (7) Notably, most of the excess risk of all-cause and cardiovascular disease (CVD) mortality for patients with diabetes is related to the presence of DKD (8).
Our Approach: CLBS201
Caladrius initiated a Phase 1 open-label, proof-of-concept study of CLBS201, a CD34+ cell investigational product for administration into the renal arteries, to improve or slow the decline of renal function in diabetic patients with CKD who exhibit rapidly progressive disease. Progressive kidney failure is associated with attrition of the microcirculation of the kidney. (9-11) Preclinical studies in kidney disease and injury models have demonstrated that protection or replenishment of the microcirculation results in improved kidney function. (12-16)
Scientific Rationale of CLBS201 Trial
- CKD is a progressive ischemic disease, characterized by increasing microvascular rarefaction, reduction in capillary density, and reduced blood flow (9-11)
- Various disease processes such as diabetes, hypertension, atherosclerosis, obesity, etc., and combinations thereof can lead to injury to the microvascular endothelium.
- CD34+ cells have been shown to contribute to repair of damaged renal tissue as a result of their angiogenic properties and hold promise for kidney regeneration (12-16)
CLBS201 Clinical Strategy
- To demonstrate that regeneration of the kidney microcirculation using CD34+ cell therapy will safely improve or stabilize kidney function [as measured by Glomerular Filtration Rate and other parameters]