CD34 Cell Technology

Ischemic Repair Program

Heart attack, congestive heart failure, critical limb ischemia, and stroke are all caused by an acute or chronic deficit in the supply of oxygenated blood. The decrease in blood supply is due to disease in the large and small blood vessels that serve the target tissues, resulting in tissue ischemia. There has been tremendous focus on strategies to address the problems in large vessels, leading to the use of clot-busting drugs, angioplasty and stents to treat heart attacks, and percutaneous and surgical revascularization for chronic ischemic conditions. In contrast no therapy has been designed to address the defect in the small blood vessels, which contributes to the overall impairment of patients with acute and chronic ischemia.

One of the bodies’ natural responses to ischemia is the recruitment of CD34 cells to ischemic tissues. CD34 cells are pre-programmed to repair damage to the small blood vessels, or microcirculation, in all tissues.

Ischemic repair: Leveraging the body’s natural repair mechanism to develop new blood vessels

Ischemic events – caused by restriction of blood to tissue, e.g., stroke, acute myocardial infarction and claudication

Results of ischemia include chronic heart failure, critical limb ischemia and more

CD34+ cells have been shown to induce the development of new blood vessels, preventing tissue death by improving blood flow

Numerous clinical studies using a patient’s own CD34 cells have shown evidence for improved function and outcome in patients with acute and chronic ischemic conditions including refractory angina, critical limb ischemia (CLI), heart failure and ST-elevation myocardial infarction (STEMI). In each of the prior 5 randomized, placebo-controlled clinical trials of CD34 cell therapy, observations were made of superior safety and clinical benefit in the treated vs. control subjects. The positive suggestion of safety and therapeutic activity seen to date in the PreSERVE-AMI trial supports this underlying platform technology and enables the Company’s exploration of more commercially viable indications of chronic heart failure and/or critical limb ischemia as targets for further development. The Company will continue to seek partnerships for all the indications in this platform, which will be necessary for Caladrius to proceed to the next steps in clinical development.