2. October 2016 Ilaria Puccini

Further long term proof of BioTissue´s technology:

12 years follow-up data on BioSeed-C presented at ICRS

In this study clinical outcome after 12 years was assessed in 21 patients with full thickness cartilage defects, using the KOOS, IKDC, Lysholm and Noyes sports activity rating scale and compared to the pre-clinical situation.

Morphologic evaluation of the repair tissue was assessed by MRI in 14 patients using the Henderson-Kreuz score and quantification of the cartilage ultrastructure in T2 mapping.

Clinical evaluation revealed significant improvement in the IKDC, the Lysholm score and the Noyes sports activity rating scale. Furthermore, both a significant and clinically meaningful improvement in the KOOS subscales Pain, ADL, Sports/Rec and Quality of Life could be observed, while Symptoms remained almost constant. Morphological evaluation by MRI showed moderate to complete defect filling in 10 of 14 patients. Interestingly, significant correlation of the parameter cartilage signal and clinical outcome was found with the IKDC, Lysholm and KOOS (subscales ADL and QoL). Quantitative evaluation of the cartilage ultrastructure by T2 mapping showed hyaline-like repair tissue in the repair site 12 years after transplantation but no correlation to the long-term clinical assessment.

These data show that the implantation of BioSeed-C leads to long-term durability of the repair tissue and improvement in the clinical outcome compared to the pre-surgical situation. This clinical follow up confirms the promising results of the mid-term follow up.