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 (<100ml) of the patient’s bone marrow. Below is a graphic illustrating Vericel’s cell expansion process.
Ixmyelocel-T is manufactured in a highly-automated, fully-closed and rigorously controlled system. The Vericel system is scalable and reproducible and located in a 5,000-square-foot centralized manufacturing facility in Ann Arbor, Michigan. (see below)
Production is done under current Good Manufacturing Practices (cGMP) guidelines required by the US Food and Drug Administration (FDA) with current annual capacity to treat up to 3,000 patients.