Developing Patient Specific Expanded Cellular Therapies
Vericel Corporation (formerly Aastrom Biosciences) is the leader in developing patient-specific expanded cellular therapies for use in the treatment of patients with severe diseases and conditions. The company markets two cell therapy products in the United States, Carticel® (autologous cultured chondrocytes), an autologous chondrocyte implant for the treatment of cartilage defects in the knee, and Epicel® (cultured epidermal autografts), a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns comprising greater than or equal to 30% of total body surface area. Vericel is also developing MACI, a third-generation autologous chondrocyte implant for the treatment of cartilage defects in the knee, and ixmyelocel-T, a patient specific multicellular therapy for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy (DCM).
The ixCELL-DCM Clinical Trial
The phase 2b ixCELL-DCM clinical trial will assess the efficacy and safety of ixmyelocel-T compared with placebo at 12 months post treatment for patients with ischemic dilated cardiomyopathy (DCM). The primary endpoint of the randomized, double-blind, placebo-controlled, multicenter ixCELL trial is a composite endpoint comprised of average per-patient number of all-cause deaths, all-cause hospitalizations, and unplanned outpatient or emergency department visits. We began enrolling and treating patients in the phase 2b ixCELL-DCM clinical trial in Q2 2013.
More information about ixCELL-DCM is available at ClinicalTrials.gov.