Problem Being Addressed:
When knee cartilage becomes damaged due to trauma, significant pain and limited movement may severely impact a person’s normal ability to function in life. Focal cartilage defects are as painful and limiting as osteoarthritis and can lead to further degradation requiring total knee replacement surgery. Focal knee cartilage injuries are typically treated by bone marrow stimulation (Microfracture procedure) which has limited benefit due to a high failure rate, poor long-term outcome and frequently required re-interventions. Various attempts to develop alternative therapeutic products in the form of cellular/biologicals treatments have failed due to the complexity and risks of the two surgical procedures required in the case of cell-based products. With the promise of cell-based procedures not realized and the recognition that microfracture provides, at best, only short-term symptom relief for patients, the pursuit of an optimal treatment for symptomatic articular cartilage defects in the knee joint remains elusive. A large market opportunity awaits teams that are able to overcome the challenges in focal knee cartilage repair. Cartilage injury afflicts over one million patients annually in Europe and there are approximately 400,000 procedures performed each year to repair cartilaginous injuries.
Importance for Society:
Focal defects are as painful and limiting as osteoarthritis – studies have shown that patients with focal cartilage lesions suffer from the same levels of pain, functional impairment and loss of quality of life as patients scheduled for total knee replacement i.e. with severe osteoarthritis. Moreover, since the patients with cartilage defects were on average half the age of the total knee replacement patients (30 yo vs. 60 yo), the cartilage patients would be expected to have to endure this disability for much longer. Focal defects eventually lead to osteoarthritis - Since adult cartilage has a poor intrinsic capacity for repair, the damage that is left untreated may result in further degeneration eventually requiring knee replacement surgery.
Objectives:
The overall objective of the project is to provide as many patients as possible an off-the-shelf, clinically proven treatment that regenerates new hyaline-like cartilage and thereby delays or prevents further joint degradation. The project supported an ongoing phase III clinical trial to provide solid evidence of the efficacy of the treatment; at the same time optimization and scale-up of the manufacturing process will ensure readiness for market launch. Commercialization activities were initiated to establish Centres of Excellence in Europe and thereby create marketing and sales channels to support market penetration.
