CD34 is a cell surface protein that identifies a subset of mononuclear cells in the bone marrow and circulation. CD34+ cells are naturally occurring, pre-programmed vascular repair cells that promote angiogenesis of the microvasculature. These cells reduce serious adverse consequences caused by damage to the inner walls of the heart’s blood vessels by generating new microvasculature and improving heart health. Preclinical studies have established the mechanism of action of CD34+ cell therapy in restoring microcirculation and improving perfusion of tissues with oxygenated blood. In addition, multiple clinical studies have demonstrated that the injection of a patient’s own CD34+ cells into the heart or legs improves clinical outcomes for patients with refractory angina, critical limb ischemia, severe intermittent claudication and dilated cardiomyopathy.
The Caladrius technology selects and delivers a potent, concentrated population of the patient’s own CD34+ cells for optimal therapeutic benefit. Caladrius has three CD34 products (HONEDRA®, CLBS14, and CLBS16) in clinical stage development.
CD34+ cell therapy is supported by a substantial body of clinical evidence
CD34+ cells have been investigated in clinical studies encompassing >700 patients
- Pre-clinical studies document improved microcirculation
- Phase 2 clinical studies consistently show benefits in safety and function
- Reduced amputation in critical limb ischemia
- Improved function in claudication
- Reduced angina and improved exercise tolerance testing (ETT) in refractory angina
- Improved mortality and left ventricular ejection fraction (LVEF) in dilated cardiomyopathy