Product Candidate for No Option Refractory Disabling Angina (NORDA)CLBS14 (formerly known as CLBS14-NORDA) has been studied in Phase 1, Phase 2 and Phase 3 randomized, double-blind placebo-controlled clinical trials. A recent publication in the European Heart Journal, entitled “Autologous CD34+ cell therapy improves exercise capacity, angina frequency and reduces mortality in no-option refractory angina: a patient-level pooled analysis of randomized double-blinded trials” combines the data from all three studies encompassing over 300 patients and reveals statistically significant improvements in mortality, exercise capacity and chest pain frequency. Under the terms of the RMAT designation, Caladrius is holding discussions with the FDA to determine the most expeditious regulatory pathway to bring this potentially restorative therapy to patients in need.
Refractory AnginaIt is estimated that as many as 1 million people in the United States have chronic symptomatic coronary artery disease (often referred to as refractory angina, or RfA) that is recalcitrant to medical therapy and not amenable to conventional revascularization procedures. Patients have reproducible lifestyle-limiting symptoms such as chest pain and shortness of breath and are easily fatigued. These symptoms are often due to totally occluded coronary arteries or to diffuse coronary atherosclerosis that makes revascularization problematic. As the population ages and the incidence of diabetes mellitus increases, this clinical condition is expected to become more prevalent. Patients with this condition have significant morbidity and experience a lower quality of life.4
1. Losordo, D.W., et al., Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: a phase I/IIa double-blind, randomized controlled trial. Circulation, 2007. 115(25): p. 3165-3172.
2. Losordo, D.W., et al., Intramyocardial, autologous CD34+ cell therapy for refractory angina. Circ Res, 2011. 109(4): p. 428-36.
3. Povsic, T.J., et al., The RENEW Trial: Efficacy and Safety of Intramyocardial Autologous CD34(+) Cell Administration in Patients with Refractory Angina. JACC Cardiovasc Interv, 2016. 9(15): p. 1576-85.
4. Ochsner J. 2009 Winter; 9(4): 220–226.