January 7, 2016 — Celyad announced Dec. 21 that the U.S. Food and Drug Administration (FDA) has authorized the company’s Investigational New Drug (IND) application for the CHART-2 trial in the United States. The phase III heart failure trial will initiate clinical testing of Celyad’s C-Cure cardiopoietic cells delivered via the C-Cath proprietary catheter.
CHART-2 is intended to assess the efficacy of C-Cure as a treatment for heart failure of ischemic origin. CHART-2 is designed as a prospective, multi-center, randomized, sham-controlled, patient- and evaluator-blinded Phase III study comparing treatment with C-Cure to a sham treatment. The trial is aimed to recruit a minimum of 240 patients with chronic advanced symptomatic heart failure.
For more information: www.celyad.com