Hyalograft ® C Autograft

Hyalograft®C autograft is a combined Advanced Therapy Medicinal Product (ATMP), which is composed of cultured expanded autologous chondrocytes seeded onto a HYAFF®based scaffold. The Italian Medicines Agency (AIFA) is the national authority responsible for drug regulation in Italy and has acknowledged that the production and control activities of Hyalograft C autograft comply with GMP standards. Hyalograft C autograft was the first autologous tissue engineered cartilage introduced in the marketplace in 1999.

Indications
Hyalograft C autograft is indicated in the treatment of full-thickness, symptomatic, single or multiple chondral defects in the knee or ankle, caused by acute or micro-traumas (grade III or IV of Outerbridge) or by Osteochondritis Dissecans.

Features
The HYAFF based scaffold allows an actual 3D arrangement of cells favoring the typical differentiation process of chondrocytes, while still in-vitro. The isomorphic structure of Hyalograft C autograft (it can be laid down on both sides on the lesion bed) together with its conformability and natural adhesiveness, makes this product an ideal candidate for the arthroscopic application, for which specific instrumentation sets have been designed.
Upon degradation, the HYAFF based scaffold spontaneously releases HA, which favors the integration and maturation of the cell construct at the lesion site.

Benefits
Hyalograft C autograft is the second generation autologous ATMP with the broadest clinical characterization and with the longest follow-up clinical data (7 yrs). Hyalograft C autograft has been demonstrated to be more effective, in terms of cartilage durability, than micro fractures at 5 year follow-up.
The simple, rapid arthroscopic implantation of Hyalograft C autograft dramatically reduces the operation time and the invasiveness of the procedure, and accelerates rehabilitation time.

Hyalograft C autograft is not currently available for sale in the United States.