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Cartilage Healing Approach Merging Polymer InnOvation with Nature

Periodic Reporting for period 3 - CHAMPION (Cartilage Healing Approach Merging Polymer InnOvation with Nature)

Reporting period: 2022-10-01 to 2023-09-30

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.
Optimization of GelrinC production process was accomplished by the creation of an environmentally friendly manufacturing process that ensures no negative effect on the environment. Clinical evidence of GelrinC efficacy is being collected in an ongoing phase III clinical trial. A multi-centre pivotal study to evaluate the safety and efficacy of GelrinC is taking place in 18 clinical centres in Europe, US and Israel. According to the clinical data gathered so far, GelrinC product appears to be safe and no adverse effects were reported. A new patent was submitted to protect the newly established manufacturing process and ensure IPR protection for the product, additional patent expansions in new countries have been obtained. For dissemination activities, the company participated in industry events and showcased GelrinC clinical efficacy in the 2019 ICRS Meeting in Rome. European Centres of Excellence to drive the product in the market have been identified.
Progress beyond the state of the art:
Unlike other acellular implants, GelrinC was designed to stimulate the formation of hyaline cartilage through a unique Mode-of-Action in which the polymer provides the pro-chondrogenic microenvironment for the body’s own stem cells to differentiate into chondrocytes. At the same time, GelrinC provides a barrier to migration of undesired cells into the defect so that new cartilage formation is restricted to the implant surface. Over time, and due to the denatured human fibrinogen in GelrinC, the implant is resorbed from the outside inwards and thus is gradually replaced with new hyaline-like cartilage in a synchronized process. This guided cartilage repair mechanism is in distinct contrast to other cartilage repair products that are both cell permeable and cell adhesive and thus promote population of the defect by a variety of cell types while providing a microenvironment that results in a fibrous tissue. In clinical studies, GelrinC has demonstrated that patients have reported a significant reduction in pain and improvement in function while radiographic imaging indicates that the regenerated hyaline-like tissue is with excellent maturation and collagen organization and content similar to normal cartilage.

Expected results:
The project aims to advance GelrinC to commercial readiness. The next steps for successful market entrance are: 1) Optimizing the production process, 2) Completing a Phase III clinical trial to gain the necessary clinical evidence that demonstrates statistically significant superiority over the standard of care treatment, and 3) Creating commercialization channels and establishing a Centre of Excellence in Europe.

Potential Impacts:
The potential impact of bringing GelrinC to the market is providing as many patients as possible an off-the-shelf, clinically proven treatment that regenerates new hyaline-like cartilage, thereby delaying or preventing further joint degradation which can lead to osteoarthritis.
GelrinC product packaging