CD34+ Cell Technology for Ischemic Repair
What is a CD34+ cell?
The CD34+ cell was discovered as a result of the deliberate search for a stem cell capable of stimulating the development and/or repair of blood vessels. All tissues in the human body maintain their function by replacing cells over time. In addition to the maintenance function, the body must also be capable of building new blood vessels after injury. A CD34+ cell is a stem cell that has the ability to stimulate new blood vessel formation. No other native cell discovered to date has demonstrated this same capability.
What is CD34+ cell therapy?
Caladrius’ proprietary CD34+ cell therapy technology has led to the development of therapeutic product candidates designed to address diseases and conditions caused by ischemia. Ischemia occurs when the supply of oxygenated blood to healthy tissue is restricted. Through the administration of CD34+ cells, the Company seeks to promote the development and formation of new microvasculature and thereby increase blood flow to the impacted area. Caladrius believes that a number of conditions caused by underlying ischemic injury can be improved through its CD34+ cell technology, including but not limited to, coronary microvascular dysfunction (CMD), critical limb ischemia (CLI), diabetic kidney disease (DKD) and no-option refractory disabling angina (NORDA).
CD34+ cell therapy is extensively studied and clinically validated
CD34+ cell therapy has been shown to consistently successfully treat a range of cardiovascular conditions associated with ischemia. Randomized, double blinded, placebo controlled clinical trials involving more than 700 patients offer compelling patient data about the safety, therapeutic effect and benefits from treating people with autologous CD34+ cells.
- 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
CD34+ cells have a well characterized mechanism of action
- Naturally occurring endothelial progenitor cells that re-establish blood flow to under-perfused tissues1,2
- Possess pre-programmed pro-angiogenic and anti-inflammatory tissue repair properties3,4
CD34+ cell process is rapid, economical and scaled
- Drug induced mobilization eliminates need for surgical bone marrow aspiration
- No genetic manipulation or ex vivo expansion of cells
- Four days or less from donation to treatment
Intellectual Property: Patent protection to 2031+
9 U.S. patents granted; 28 foreign patents granted
- Pharmaceutical composition of non-expanded CD34+/CXCR4+ stem cells
- Therapeutic concentration range
- Stabilizing serum
- Repair of injury caused by vascular insufficiency