Enhancing organ transplantation

Transplantaon is a life saving and life-transforming treatment for people with end-stage organ disease. In the face of increasing demand, therapies to improve the quality of donated organs are essential.

Ex situ machine perfusion allows isolated donated organs to be kept alive and treated outside of the body.

Cellular therapies have shown great promise. But delivering whole cells into donated organs introduces risks and regulatory hurdles.

This device allows the benefits of cell therapies to be delivered, whilst avoiding the risks of whole cell delivery.

By enhancing organ during ex situ machine perfusion, the technology aims to increase the success rate of transplants and expand the pool of usable donor organs.

Technology overview

The device maintains the cellular therapy cells within a hollow fiber bioreactor unit. It can be attached in parallel to existing organ machine perfusion or extracorporeal circuits.

The fibers permit two-way exchange of soluble factors and extracellular vesicles between the donated organ and the cells. The cells themselves cannot cross the fibers.

Consequently, the cells receive activation signals from the donated organ (e.g. kidney). This produces protective factors which cross the fibers and reach the organ.

This delivers the benefits of the cells, without delivering whole cells into the donated organ (which would then be transplanted with the organ).

Benefits

Built-in temperature control of the cell therapy compartment

This is key as our research has shown that the existing approach of heating the liquid perfusate (seen in all available machine perfusion devices) is inadequate to maintain the temperature of the cell therapy compartment.

Cross-compatability

The technology can be used with a range of cell types including mesenchymal stromal cells.

Stand-alone or parallel use

A stand-alone module which can be added to any existing ex situ or extracorporeal circuit as a parallel limb.

Cells are separate from the organ

Due to the physical separation of the cells from the organ, the cells themselves will not enter the organ (e.g. kidney) and would therefore not be transplanted into the patient.

Reduced risk

This device could de-risk cellular therapies for organ tranplantation and alleviate potential regulatory hurdles as the technology is progressed towards the clinic.

Applications

This device would allow delivery of cell therapies during ex situ machine perfusion of donor organis such as kidneys, livers, hearts, and lungs. This could lead to better transplant outcomes and expand the donor pool.

In addion to the treatment of donor organs, this device could also be used as a parallel limb in extracorporeal circuits used to treat the whole patient. Example uses include:

• combine with haemodialysis and hemofiltraon systems for treating severe acute kidney injury.
• incorporate into extracorporeal membrane oxygenaon (ECMO) circuits to deliver cellular therapies for severe sepsis, respiratory
  failure, fulminant liver failure, and systemic inflammatory response syndrome.

In these settings, the benefits of cell therapies could be delivered, whilst avoiding the risks of whole cell delivery.

Markets

Markets for this technology include:

• Healthcare providers, paarticulalry hospitals specializing in organ transplantation and crical care.
• Assessment and recondioning centres, which are being developed globally with the aim of treating donated organs whilst they are outside of the body.
• Medical device manufacturers:
  • machine perfusion devices
  • haemodialysis machines
  • hemofiltraon units
  • ECMO systems
• Biotechnology companies
  • cellular therapies
  • regenerave medicine products

We are seeking opportunies to collaborate with medical device companies, healthcare providers, and research instuons interested in enhancing organ quality, reducing the risks associated with direct cell delivery and improving transplantaon outcomes.

We aim to partner with teams focused on developing cellular therapies for organ transplantation, kidney failure treatments, and extracorporeal support systems such as haemodialysis and ECMO.

Contact

For further information, please contact:

• Dr Anastassia Kostenko, Associate IP and Commercialisation Manager
• anastassia.kostenko@newcastle.ac.uk