Date: 2015-01-29
Type of information: Completion of patient enrollment
phase: 2b
Announcement: completion of patient enrollment
Company: Vericel (formerly Aastrom Biosciences) (USA - MA)
Product: ixmyelocel-T
Action
mechanism: cell therapy. Ixmyelocel-T is a patient-specific, expanded multicellular therapy, manufactured using Vericel’s proprietary, highly automated, fully closed cell-processing system. Vericel’s patent-protected technology selectively expands mesenchymal cells, monocytes and alternatively activated macrophages, up to several hundred times more than the number found in the patient’s bone marrow, while retaining many of the hematopoietic cells collected from only a small sample (50ml) of the patient’s bone marrow.
Disease: advanced heart failure due to ischemic dilated cardiomyopathy
Therapeutic area: Cardiovascular diseases
Country: Canada, USA
Trial
details: This study is designed to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo (vehicle control) when administered via transendocardial catheter-based injections to patients with end stage heart failure due to ischemic dilated cardiomyopathy , who have no reasonable revascularization options (either surgical or percutaneous interventional) likely to provide clinical benefit (NCT01670981).
Latest
news: * On January 29, 2015, Vericel Corporation, a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, announced the completion of patient enrollment in the company\'s Phase 2b ixCELL-DCM clinical trial evaluating ixmyelocel-T for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy (DCM). Top-line results from this study are expected around the end of the first quarter of 2016.
