Founded in 1989, Vericel (formerly Aastrom Biosciences) is dedicated to the development of patient-specific expanded cellular therapies for use in the treatment of patients with severe diseases and conditions.
The company currently 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. Vericel is also developing MACI™, a third-generation autologous chondrocyte implant product, as well as ixmyelocel-T, a patient specific multicellular therapy for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy (DCM).
Leaders in cell therapy manufacturing
Vericel’s historic focus on cell therapy and regenerative medicine took a major step forward in May 2014 when the company acquired the global marketing rights to three landmark autologous cell therapies from the Genzyme division of Sanofi:
• CARTICEL is the first and only FDA-approved biologic product used to repair articular cartilage injuries in the knee. It is manufactured using a patient’s own cartilage cells and is implanted in a surgical procedure known as autologous chondrocyte implantation (ACI). Once implanted, the cells have been shown to form new hyaline-like cartilage, with properties similar to normal cartilage, and may reduce pain and improve knee function.
• EPICEL is FDA approved as a humanitarian use device (HUD) and is indicated for use in patients who have deep dermal or full thickness burns comprising a total body surface of greater than or equal to 30%. EPICEL, which is essentially thin sheets of epidermis, is manufactured from a small sample of patients’ skin.
• MACI is a third-generation ACI product for the treatment of articular cartilage injuries in the knee. It has been approved but is not currently marketed in Europe. In June, Vericel announced that following discussions with the U.S. Food and Drug Administration (FDA) the company plans to submit a Biologics License Application (BLA) to the FDA by the end of 2015 for MACI for the treatment of focal chondral cartilage defects in the knee. MACI has potential advantages of a shorter, less-invasive surgical procedure and a faster recovery period than CARTICEL.
For more than 20 years, the research and production teams responsible for CARTICEL and MACI have been focused on superior performance in autologous cell therapy manufacturing establishing industry standards.
A) CARTICEL PROCESSING: Vericel’s cell processing manufacturing facility uses specific enzymes to free cartilage cells (chondrocytes) from the cartilage matrix. The chondrocytes