DeNovo® ET Living Cartilage Implant

Cartilage damage resulting from sports injuries or traumatic accidents sparks a degenerative cascade that can cause severe pain and disability. Once the cycle of joint cartilage degeneration begins, patients are left with few good treatment options and often suffer irreparable damage to their cartilage and underlying bone. This may eventually lead to artificial knee replacement and its associated limitations. Most estimates suggest that only 10% of patients suffering from osteoarthritis have a condition serious enough to warrant a surgical remedy. This leaves a significant patient population with chronic pain and reduced mobility in need of alternative treatments.

DeNovo® ET, a scaffold-free, living cartilage implant, offers a one-step alternative to current cartilage repair. Designed to be offered as a product for the repair and regeneration of knee cartilage, DeNovo ET is applied to defects of the joint surface using a protein-based adhesive in a simple one-step procedure. DeNovo ET is hyaline cartilage, displaying biochemical properties similar to those of articular cartilage found in young, healthy joints.¹

Because cells used to produce DeNovo ET are derived from juvenile tissue, DeNovo ET is expected to heal and regenerate damaged joint cartilage more effectively than technologies that use adult cells. Pre-clinical testing has demonstrated the ability of DeNovo ET to integrate with native cartilage and bone while retaining its hyaline properties.²

ISTO has partnered with Zimmer, Inc. to develop and commercialize DeNovo ET. Subjects in a Phase I/II clinical trial in the U.S. for the treatment of cartilage defects to restore joint function and to provide relief of knee pain have all reached the 3-year follow-up point.

ISTO is currently enrolling subjects in the Phase III DeNovo ET clinical trial. For more information about this study, please click here or go to www.repairmyknee.com.

1. Adkisson HD, IV, Gillis MP, Davis E C, et al. In vitro generation of scaffold independent neocartilage. Clin Orthop Rel Res 2001; 391S:S280-S294.
2. Lu Y, Adkisson HD, Bogdanske JP, et al. In vivo transplantation of neonatal ovine neocartilage allografts: determining the effectiveness of tissue transglutaminase. J Knee Surg 2005; 18:31-42.

Preclinical studies show that DeNovo ET can be used to resurface surgical defects created in the knee. Integration of the living cartilage implant at the graft/host junction is shown above at gross necropsy (top) and upon histological examination (bottom). Safranin O/fast green stain was used to visualize matrix proteoglycan.