Regenerative therapy for diabetic kidney disease

Diabetic Kidney Disease: Chronic Kidney Disease and Type 2 Diabetes - LSTA201

What is Chronic Kidney Disease (CKD)?

Chronic kidney disease (CKD), also called chronic kidney failure, is a growing health problem. Chronic kidney disease is the gradual loss of kidney function over time. 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; 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 higher than in patients with diabetes without kidney disease (2),(3).

How does DKD affect patients with diabetes?

Diabetic kidney disease is a serious complication that can occur in patients with Type 1 and Type 2 diabetes. DKD can lead to kidney failure and is a major cause of death in patients with diabetes. Patients with DKD often experience a decline in kidney function. This can lead to a build-up of toxins in the blood and an increase in the risk of cardiovascular disease. Patients with DKD also have a higher risk of developing infections. It is important for patients to be aware of the signs and symptoms of DKD, and to seek medical help if they experience any of these.

DKD represents a large unmet medical need

The increasing prevalence of diabetic kidney disease 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).

Chronic kidney disease 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: LSTA201 for the treatment of diabetic kidney 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). Based on these observations, the Company initiated a Phase 1, open-label, proof-of-concept trial evaluating LSTA201 (formerly known as 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 was to evaluate the tolerance of intra-renal cell therapy injection in DKD patients as well as the ability of LSTA201 to regenerate kidney function. For more information on this study, please visit (identifier: NCT04990427).

Development Rationale Of LSTA201 in patients with Chronic Kidney Disease (CKD) and Type 2 Diabetes

  • CKD is a progressive ischemic disease, characterized by increasing microvascular rarefaction, reduction in capillary density, and reduced blood flow (9-11)
  • 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)
  • Therapies currently available and/or expected to be available over the next 5–10 years will slow the progression of CKD/DKD
  • An effective regenerative DKD therapy (i.e., one that reverses the course of the disease) could represent a medical and pharmacoeconomic breakthrough

LSTA201 Clinical Strategy

  • To demonstrate that CD34+ cell therapy (mobilization, donation and administration) can be tolerated by patients with CKD with Type 2 Diabetes
  • 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]
LSTA201 (U.S.)
Pre Clinical Phase 1 Phase 2 Phase 3
Phase 1b (Proof-of-concept)
Phase 1
Indication: Diabetic Kidney Disease
Partner/Sponsor: Lisata | Location: United States
Next Development Milestone: Data expected 1Q23
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