HEALIKICK
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A bioengineered graft for improved bone regeneration
Bone regeneration using engineered grafts must guide the growth of new bone and enable it to integrate into the surrounding tissue. To facilitate this process and improve bone regeneration, the EU-funded HEALIKICK project is working on a novel combinatorial approach that employs a granular graft material with a highly osteogenic coating seeded with pre-differentiated osteogenic adipose mesenchymal stromal cells (MSCs). Scientists will validate this approach initially in pre-clinical studies, with the aim to submit the required regulatory and technical developments for clinical trial. They will also undertake the necessary optimisation and development activities to adapt this approach for the treatment of large bone defects.
Objective
Disruptive technologies for bone regeneration must be able to tackle complex fracture environments which have developed into non-union bone defects. These types of fracture are common and increasingly prevalent when considering the rise in osteoporosis cases. 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 adipose 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. The novel technologies will be developed into a new medical device and a new cellular therapy with pre-clinical validation for their co-administration. 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. In parallel to the core therapy we will expand the therapeutic pipeline by replacing the granular graft with 3D printed polymeric scaffold, again including including a highly osteogeneic coating, as a carrier for the cell therapy. Targeting even larger bone defects, this scaffold will be co-administered with the cellular therapy in pre-clinical efficacy studies.
