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FORNY20-FORNY2020

3D-printed polymer scaffolds for bone regeneration

Alternative title: 3D-printede implantat for behandling av beinskader

Awarded: NOK 5.0 mill.

Project Number:

295809

Project Period:

2019 - 2023

Funding received from:

Location:

Partner countries:

Accidents, as well as bone ailments like osteoporosis and cancer, often result in the loss of both small and substantial sections of the long bones in our arms and legs due to either the initial injury or surgical intervention. In such instances, the gap in the fractured or injured bone does not naturally close on its own. In most cases, when the missing bone fragment is small, this gap is typically mended by employing a natural bone graft derived from another location within the patient's own body. However, in cases where patients lack sufficient healthy bone for transplantation, alternative approaches involve the use of bone grafts from deceased donors or the utilization of artificial implants crafted from synthetic materials. Nevertheless, these donor grafts or synthetic implants can exhibit instability, leading to prolonged and intense pain, thereby restricting the patient's mobility in their daily life. Additionally, donor grafts may carry the risk of disease transmission, while synthetic materials may not facilitate complete bone healing and may possess inadequate mechanical strength or an improper shape. Every year, the United States and Europe collectively face the daunting challenge of treating over 0.5 million patients grappling with these issues. Our cutting-edge 3D-printed bone technology presents a novel solution, offering a scaffold constructed from medically safe synthetic materials with mechanical attributes and shapes closely resembling those of natural bones. This implant can be infused with the patient's own stem cells and hydrogels, fostering an environment conducive to the growth of cells and blood vessels within the scaffold. With this groundbreaking technology, physicians have the capability to design an exact replica of the missing bone segment based on injury images and produce it using a 3D printer. Our success in testing this technology in sheep, whose bone properties closely mirror those of human bone, has focused on evaluating its biocompatibility and propensity for dislocation. Our next critical step involves assessing the safety and functionality of the scaffold in a model simulating segmental bone defects. We will scrutinize the formation of new bone within the implant body and its connections to the natural bone. We firmly believe that 3D-printed bones hold immense potential to revolutionize the landscape of bone loss treatment.

The goal of this project was to test the 3D-printed polymer scaffold on its own and in combination with stem cells, ceramic materials and/or hydrogels. The preliminary data indicated a combination that gives a primising results and should be investigated further for its fuctionality. Assuming positive outcome of this testing, we will have aclinical trial-ready technology, which has the potential to revolutionize the landscape of bone loss treatment. The feedback from the key opinion leader in the orthepedy filed indicated that there is high probability of use of this technology not only for special cases, as primary application indicate, but also in a long-term it could replace gold standard-autologous graft, providing comparable efficiency and pricing. Scaffold requires no additional operational site to harvest bone for transplant as autografts, which often results in complications. This will shorten patient’s recovery time, lower the cost and amounts of medical waste by hospitals, and improve patient’s physical disability and mental health problems related to long-term pain experience.

Funding scheme:

FORNY20-FORNY2020