CLBS14

Product Candidate for No Option Refractory Disabling Angina (NORDA)

NORDA is a severe end-stage condition which results in disabling symptoms due to extensive coronary disease that has not responded to bypass surgery, stenting or medications. CLBS14 has been studied in Phase 1, Phase 2 and Phase 3 randomized, double-blind placebo-controlled clinical trials. 1-3 Recent publications in the European Heart Journal4 and Cardiovascular Revascularization Medicine 5, 6, provide an independent analysis of the evidence from these studies and reveal significant improvements in exercise capacity, angina frequency and mortality in this orphan sized patient population. 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.

References:

  1. Losordo DW et al. Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: a phase I/IIa double-blind, randomized controlled trial. Circulation 2007; 115: 3165-3172,
  2. Losordo DW, et al. Intramyocardial, autologous CD34+ cell therapy for refractory angina. Circ Res 2011; 109: 428-436, doi:10.1161/CIRCRESAHA.111.245993.
  3. Povsic TJ, et al. The RENEW Trial: Efficacy and Safety of Intramyocardial Autologous CD34(+) Cell Administration in Patients With Refractory Angina. JACC Cardiovasc Interv 2016; 9: 1576-1585, doi:10.1016/j.jcin.2016.05.003.
  4. Henry TD, et al. 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. Eur Heart J 2018, doi:10.1093/eurheartj/ehx764.
  5. Velagapudi P et al. Intramyocardial autologous CD34+ cell therapy for refractory angina: A meta-analysis of randomized controlled trials. Cardiovascular Revascularization Medicine : including molecular interventions 2019; 20: 215-219, doi:10.1016/j.carrev.2018.05.018.
  6. Benck L, Henry TD. CD34+ Cell Therapy for No-Option Refractory Disabling Angina: Time for FDA Approval? Cardiovascular Revascularization Mmedicine : including molecular interventions 2019; 20: 177-178, doi:10.1016/j.carrev.2019.01.012.