Matrix Supported Autologous Chondrocyte Transplantation
NOVOCART 3D is a unique biologic-device combination product under investigation within the United States for repair of articular cartilage of the knee (femoral condyle and trochlear groove). The product has been in commercial use since 2003 in the European Union and more than 8,000 patients have been treated. The procedure takes place over the course of three weeks and involves two surgeries.
This next generation concept for articular cartilage repair begins with three cartilage tissue biopsies taken from a non-weight bearing portion of the knee during an arthroscopic procedure. These biopsies are sent to the Aesculap Biologics, LLC manufacturing facility where the chondrocytes are isolated and expanded under the guidelines of Good Manufacturing Process. The cells are minimally passaged to prevent de-differentiation. Near the end of the process, the chondrocytes are seeded onto the biphasic collagen scaffold.
Manufacture of NOVOCART 3D
The manufacturing process is managed with careful testing for quality (identity, purity and potency) and sterility. Each patient’s cells are treated as a separate manufacturing batch and carefully managed for traceability. Approximately three weeks after the harvest of the biopsy, release testing is completed and the NOVOCART 3D implant is shipped to the surgery center.
The architecture of the scaffold device is a defining feature in development of NOVOCART 3D. The scaffold consists of a porous spongy side, which allows for distribution of cells within the scaffold, and a layer of tough collagen membrane cover. The spongy portion of the scaffold has an organized three-dimensional pattern of fibers sized to allow the chondrocytes to adhere to the scaffold without losing their signature shape. The tough collagen membrane layer protects the chondrocytes after implantation and allows for easier handling within the surgical site.
Upon return of NOVOCART 3D to the surgery center, the patient is prepared for implantation using a mini-arthrotomy surgical procedure. The cartilage lesion is prepared and debrided to clean edges. The scaffold is shaped to match the exact contours of the prepared lesion with scissors, scalpel or tools. Once the implant is shaped, it is affixed to the defect with 6-10 sutures. Bioresorbable mini-pins may also be used if the edge of the native cartilage or the location of the defect does not allow for suturing.