Aesculap Biologics achieved 50% enrollment in an ongoing Phase III clinical trial of NOVOCART® 3D, an autologous chondrocyte transplantation system designed to treat knee articular cartilage defects. Approximately 117 study participants have been treated.
The prospective, randomized, partially blinded study, which began in 2014, will enroll a total of 233 participants in the U.S. and Canada. It is designed to compare NOVOCART to microfracture, the current standard of care. Study results will support the pursuit of regulatory approval in the U.S.
NOVOCART 3D was developed in Germany, and has been used in the EU to treat >18,000 patients since 2003. The investigational biologic/device combination product comprises an implant derived from the patient's own cartilage cells, obtained through a cartilage biopsy from a non-weight bearing location in the knee. Tissue is sent to the Aesculap Biologics manufacturing facility where the cartilage cells are isolated and grown in culture; after three weeks, they are added onto a collagen device and returned for implantation in the defect.
Presently, Vericel's MACI is the only FDA-approved autologous chondrocyte implantation product on the U.S. market. Earlier in 2019, Histogenics announced expectations to suspend development of its NeoCart® tissue engineered implant candidate based on FDA feedback for its Phase III clinical trial, which indicated that an additional clinical trial would be required to accept a Biologics License Application.