CLBS201 is designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for diabetic kidney disease ("DKD"). 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 of the disease or even reverse the course of DKD. We plan to file an IND for this program by the second quarter of 2021 and to initiate a phase 1/2 proof-of-concept study of CLBS201 in a moderate to severe DKD population shortly thereafter. DKD remains a largely unmet medical need, especially as the general population ages and the incidence of diabetes and hypertension increases.
Scientific Rationale of CLBS201 Trial:
- CKD is often associated with progressive microvasculature damage and loss, resulting from its common comorbidities of hypertension and diabetes1
- The pathophysiology of CKD denotes compromised renal microvasculature2
- Preclinical studies show that microcirculation replenishment improves kidney function
- CD34+ cells are promoters of new capillary growth, improving the microvasculature
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 GFR]
- To show that progression to kidney failure and hemodialysis can be slowed or prevented
- Chade AR. (2017) Small Vessels, Big Role: Renal Microcirculation and Progression of Renal Injury. Hypertension; 69(4):551-563.
- Zuk, Anna & Bonventre, Joseph. (2016). Annual Review of Medicine. 67. 293-307. 10.1146/annurev-med-050214-013407.