Caladrius Biosciences is developing innovative products to treat cardiovascular and autoimmune diseases. We have four programs in mid to late stage development centered around two different proprietary technologies, each of which offers multiple product opportunities. Our carefully selected programs involve disease areas in which Caladrius’s management team has significant expertise, where there is a recognized significant unmet medical need and where we believe we can compete effectively.
Our CD34+ cell technology has led to the development of HONEDRA® (formerly CLBS12), a product designed to stimulate the growth of microvasculature and address diseases and conditions caused by limb ischemia. Through the administration of CD34+ cells, we seek to promote the development and formation of new micro blood vessels and thereby increase blood flow to the ischemic area. We currently have a pivotal Phase 2 trial investigating HONEDRA® (a candidate for critical limb ischemia) underway in Japan. HONEDRA® has received SAKIGAKE designation for expedited development and review and has been deemed eligible for consideration of early conditional approval by the Japanese regulatory authorities.
Our CD34+ cell technology also has potential to address multiple cardiovascular diseases. CLBS14 is currently in late-stage development in the USA and received RMAT designation from the FDA for the treatment of no-option refractory disabling angina (NORDA).
CLBS16, the subject of a recently completed positive ESCaPE-CMD Phase 2 clinical trial in the USA for the treatment of coronary microvascular dysfunction (CMD).
CLBS119 is Caladrius’ CD34+ cell therapy product candidate targeting repair of COVID-19 induced lung damage. The FDA has authorized administration of CLBS119 under its Expanded Access IND Guidelines to evaluate the safety and efficacy of autologous, peripheral-blood-derived CD34+ cells for repair of COVID-19 induced lung damage in patients who have suffered respiratory failure.
CLBS03 is an autologous ex vivo polyclonal T regulatory cell ("Treg") clinical Phase 2 therapy targeting adolescents with recent-onset type 1 diabetes mellitus. This program evolved from our second technology platform involving the use of Tregs to treat diseases caused by imbalances in an individual's immune system. This novel approach seeks to restore immune balance by enhancing Treg number and function to treat and ultimately eliminate autoimmune diseases.