IND Approval Granted For Zimmer/ISTO Technologies' Neocartilage Graft
BY ARIELLA P. GOLOMB, MD, JUNE 21, 2006
Each year, hundreds of millions of people injure the cartilage in their knees, shoulders and other joints. Today Zimmer Holdings and ISTO Technologies announced that the U.S. Food and Drug Administration (FDA) has approved ISTO's Investigational New Drug (IND) application for Neocartilage, a novel cartilage regeneration treatment. (IND approval allows the initiation of human clinical trials). The announcement claims that the potential market for Neocartilage is large, as approximately 500,000 cartilage lesions are treated in knee joints each year in the United States alone.
Neocartilage is generated from juvenile rather than adult chondrocytes. The companies state that ISTO's patented technology allows expansion of the chondrocytes and the creation of a tissue graft while maintaining both their functional and repair capacities. As explained on ISTO's website, Neocartilage will be the only scaffold-free living cartilage graft on the market. ISTO's development pipeline also includes NuQuTM, a cell based injectable formulation of juvenile cartilage cells targeted for nucleus regeneration in the disc.
Based on the rights from a 2002 agreement between the two companies, Zimmer plans to market the product as DeNovo(R) ET Live Chondral Engineered Tissue Graft. However, today's press release did not mention the extent or design of the study program and there may be a good deal of development time required prior to launch. The initial implantations in the human clinical trials are not expected until the second half of this year.
Of note, as we previously reported there are other novel mechanisms to replace cartilage being developed, such as the transduction of muscle stem cells.
