Periodic Reporting for period 2 - HEALIKICK (A modular strategy for the repair of critical sized bone fractures)
Reporting period: 2021-12-01 to 2023-05-31
Disruptive technologies for bone regeneration must be able to tackle complex fracture environments that have developed into non-union bone defects. These types of fractures are common and increasingly prevalent when considering the rise in osteoporosis cases alone. We aim to develop graft technologies that will provide the efficacy of an autograft with the benefits of being an off-the-shelf product. Bioengineered bone graft systems need to be able to guide the regrowth of new bone into substantial voids and therefore implants pre-seeded with mineralising cells are of significant clinical interest. We will implement a surgical co-administration of two robust technologies 1) a granular graft material with a highly osteogenic coating that presents relevant biologics very efficiently and 2) pre-differentiated osteogenic mesenchymal stromal cells (MSCs) that together will underpin efficient bone regeneration. Within the project we aim to take these two technologies into GMP and ISO rated manufacture as required for any clinical therapy. We will then implement these therapies in pre-clinical studies to obtain efficacy and safety data to support a full clinical trial application. Our aim is to develop these technologies into a new medical device and a new cellular therapy with pre-clinical validation for their co-administration.
Throughout the project so far, we have made significant progress in the development of our novel bone regeneration technologies. We have successfully transferred production of our osteogenically primed mesenchymal stromal cells (aMSCs) and our highly osteogenic coated graft material from an academic setting to GMP manufacturing. We have also made progress to further advance manufacturing readiness to future proof our technologies to make production more commercially viable for larger patient groups. Furthermore, through health economic assessment, we gained further understanding of the economic headroom for new clinical therapies in this area. Initial in vivo efficacy testing of our technologies has yielded positive results and we have commissioned an external CRO to begin GLP safety testing. The results of these studies will be used towards building a pre-clinical data package to support production of an Investigational Medical Product Dossier (IMPD) and clinical trial application (CTA).
We have hosted two Translation Days for invited clinicians to share progress on the project to date, gain feedback and build relationships for future research development and clinical trials. As a result of these sessions, in principle, we have identified a group of sufficient clinician interest across Europe to run a multi-centre trial of non-union repair in the future. As a consortium, we have highlighted and presented results of the project to date at local, national, and international conferences aimed at relevant scientific, clinical and other industrial stakeholders. We have also participated in public engagement events with demonstrations and activities to exhibit our HEALIKICK technologies to the wider public. Results produced from the project have also been shared in open access, peer reviewed journal publications.
We have hosted two Translation Days for invited clinicians to share progress on the project to date, gain feedback and build relationships for future research development and clinical trials. As a result of these sessions, in principle, we have identified a group of sufficient clinician interest across Europe to run a multi-centre trial of non-union repair in the future. As a consortium, we have highlighted and presented results of the project to date at local, national, and international conferences aimed at relevant scientific, clinical and other industrial stakeholders. We have also participated in public engagement events with demonstrations and activities to exhibit our HEALIKICK technologies to the wider public. Results produced from the project have also been shared in open access, peer reviewed journal publications.
There is a widespread clinical and economic need for cost-effective bone graft substitutes that can restore functional outcome and improve patient quality of life. Non-union fractures are common, and their treatment is a significant healthcare burden, particularly when considering the growing incidence of osteoporosis fragility fractures alone. This modular application of two highly advanced therapies is itself highly novel in terms of clinical strategy and by the end of the project we aim to have made the required regulatory and technical developments to submit them for clinical trial. By developing innovative bone graft solutions for complex fractures, non-union or mal-union conditions, we hope to improve clinical outcomes of current complex injuries and enable currently unrealisable treatments to repair defective, diseased bone tissues caused by trauma and aging.