The iDISC platform has been developed as an injectable hydrogel system designed to replicate the biochemical and mechanical properties of the native intervertebral disc (IVD), serving as both a filler and a regenerative hydrogel. The system includes formulations targeting the nucleus pulposus (NP) and annulus fibrosus (AF), providing structural reinforcement, bioadhesion, and cellular support within degenerated discs. The AF hydrogel was synthesised and combined with AF extracellular matrix nanofibres (AFNF). The fibrous AFNF network significantly enhanced mechanical performance, with the AFNF formulation achieving an aggregate modulus within the physiological range of native AF tissue. Tensile testing confirmed improvements in strength and modulus comparable to standard clinical adhesives. The NP hydrogel, developed using modified NP ECM, exhibited biomechanical and biochemical properties similar to native NP tissue. Its bioadhesive strength was comparable to fibrin glue, supported by interactions with tissue proteins. Both AF and NP hydrogels exhibited good biocompatibility, supporting cell viability and disc-specific ECM production. Injection tests confirmed minimal shear-induced damage to encapsulated cells, while histology analysis revealed collagen type II and Sox9 expression consistent with disc regeneration. Ex vivo evaluation demonstrated the hydrogels’ ability to adhere securely and withstand physiological compression and torsion in bovine disc models. In degenerated goat disc models, NP and cell-laden hydrogels maintained cell viability and integrated seamlessly with native tissue confirming their potential as cell delivery vehicles and biomechanical stabilisers. Preclinical evaluation in a caprine disc degeneration model, confirmed the hydrogel’s safety over four months post-implantation.
A market assessment has been completed to evaluate the commercial potential of the iDISC platform. The analysis identified a clear market gap for regenerative biomaterials targeting intervertebral disc repair, supporting the feasibility of translation into a clinical product. A European patent application titled “An extracellular-matrix-derived gel composition” has also been filed to protect the intellectual property arising from the ERC INTEGRATE and ERC Proof of Concept (PoC) iDISC projects. The data generated so far demonstrate strong commercialisation potential, and future steps will focus on conducting longer-term animal studies under GMP conditions to validate safety and efficacy. Plans are underway to establish a spin-out company and initiate fundraising to support regulatory translation and product development. In summary, the iDISC project has successfully developed a series of ECM-derived injectable hydrogels for intervertebral disc regeneration, combining mechanical performance, bioadhesion, and cellular compatibility. The system shows promise as a translational platform for minimally invasive treatment of disc degeneration. Current work is directed toward process optimisation, scale-up, GMP validation, and commercial development for future clinical application.
