Theme 5: Tissue Engineering for Regenerative Medicine

Challenges

The RM field is faced with an extensive range of challenges. Some suggestions by the author are:

  • Managing complexity more effectively, especially of cells in the process environment; going from monolayers [≤500μm] to bigger 3D constructs, including whole organs or organoids.
  • Achieving effective vascularisation of all manufactured tissues, with particular attention on tissues >500μm thickness; achieving innervation of all manufactured tissues.
  • Achieving [greater] functional integration between: laboratory-cultured cells; the scaffolds and biomaterials [natural, synthetic and combined] used to guide and support in a controlled way the cells’ growth, differentiation and proliferation; and the action of growth factors.
  • Increasing understanding of the effects of exogenous mechanical [and other environmental] forces on the growth, differentiation and proliferation of cells; developing greater ability to influence and/or control this interaction.
  • Developing [greater] expertise, at the lab bench in the first instance, in applying two or more technologies in synchrony or in intimate sequence to build target tissue with all essential structure and functions e.g. electrospinning with fused deposition modelling and/or bioprinting.
  • Translating laboratory-scale technologies to clinically effective [and cost-effective] systems of manufacture; developing robust procedures/techniques for scaling.
  • Developing understanding about comparability between manufacturing sites and the measures needed to achieve this complementarity.
  • Building safe and effective ‘factory-to-clinic’ procedures in respect of cell banking, cell/tissue preservation, packaging, transport and delivery, inventory management, and in-transit cell tracking.
  • Reconciling manufacturing models for scale-out/roll-out of clinically-led autologous therapies with regulatory requirements for inter-site comparability, taking into account the economics of ‘larger’ up-front/one-off reimbursement for permanent therapeutic solutions [auto] versus a regime [allo] that may trigger cell/tissue rejection and is thus be characterised by continual reimbursements for repeated clinical interventions.
  • Forging stronger communications between the academic/research community and relevant industry, and mutual professional understanding and recognition between all players.
  • Securing full involvement of clinical ‘trail blazers’ in the CBP development process, preferably not later than the start of the design and specification stage.
  • Promoting understanding and acceptance by the general public, and the rapid uptake by clinicians, of new cell-based therapies.