Vericel Corp (NASDAQ:VCEL) has announced the publication of clinical trial rationale and study design for the company’s phase 2b ixCELL-DCM trial of ixmyelocel-T in patients suffering from advanced heart failure due to ischemic dilated cardiomyopathy (DCM). The publication has been made in the journal Cell transportation. Earlier on the company had announced that ixCELL-DCM trial had met its primary endpoint by demonstrating a reduction in the number of deaths, cardiovascular hospitalization, emergency department visit, unplanned outpatients and emergency visit to treat acute decompensated heart failure during 12 months after treatment with ixmyelocel-T compared to placebo.
The ixCELL-DCM trial is believed to be the largest randomized, double-blind and placebo-controlled cell treatment clinical trial to treat heart failure as a result of ischemic DCM. Dr. Timothy Henry and Henry T.D., Schaer G., Demaria A., et al., created the publication (The ixCell-DCM Trial: Rationale and Design, Cell Transplantation, 2016). They described study design, study population, treatment preparation and protocol, statistical analysis plan, clinical endpoints for the ixCELL-DCM clinical trial.
The full data results from the ixCELL-DCM trial are expected to be presented at the upcoming Late-Breaking Clinical Trial Session of the American College of Cardiology on April 4, 2016. The report will also be submitted for publication.
In other news, Vericel announced their financial result and business highlight for the fourth quarter and the year that ended December 31, 2015.The total net revenue was approximated at $15.4 million. About $11 million of this was the net sale of Carticle implants and surgical kits while approximately $4.1 million were the net sale of Epicel. The total revenue for Carticel and Epicel in the fourth quarter was approximated at 5% higher over the same period in 2014.
Vericel Corporation focuses on developing patient-specific expanded cellular therapies that are to be used to treat various severe disease and condition. The company markets two autologous cell therapy products in the U.S.
One is Carticel- an autologous chondrocyte implant that is used to treat cartilage defects in the knee and an Epicel- a permanent skin replacement used to treat patients with a deep dermal or full-thickness burn that are greater or equal to 30% of total body surface area.