Transplant

Organ transplantation is currently the treatment of choice for patients with advanced organ failure. To date, the limiting factor in its application is the shortage of suitable organs which faces an ever-increasing demand. The consequence is lengthening waiting lists and the need to broaden donor selection criteria, to the ‘extended criteria’ (by age, presence of comorbidities, cause of death). This is called Extended Criteria Donor (ECD).

On the one hand, it is necessary to guarantee the use of every organ, even marginal ones, which are compromised by complex biological reactions and the processes involved in procurement and preservation. On the other, it is necessary to optimise the outcome of the transplant. In this context, it is crucial to act on:

  • the management and implementation of existing procedures, such as, among others, that of transportation
  • new strategies for organ preservation and reconditioning, such as perfusion, both in the donor (in-situ), after retrieval and before transplantation (ex-situ). This approach is emerging as one of the possible strategies for organ recovery, maintenance, assessment, and treatment to enhance transplant outcomes.

Aferetica aims to contribute to a significant breakthrough in the availability of transplantable organs and in the outcomes of transplants themselves, by developing comprehensive therapeutic solutions dedicated to:

Organs

  • IN-SITU The evolution of in-situ conditioning, combining aphaeretic purification systems with ECMO assistance during Normothermic Regional Perfusion (NRP) procedures
  • TRASPORT with modules dedicated to organ preservation in a controlled and protected environment during transfer to the transplant centre
  • EX-SITU PERFUSION The development of comprehensive systems for the maintenance and reconditioning of organs ex-situ, including equipment, containers, circuits, cannulas, dedicated fluids, transport modules, and sorbents, integrating perfusion and modulation of the inflammatory response.

Patient-dedicated Apheresis Therapies

  • Aphaeretic therapies dedicated to the patient, assisting in managing inflammatory processes and immune complications during the pre-, peri-, and post-transplant phases.

ABO incompatible transplantation Antibody-mediated rejection

“To Give More Chance to Life”

The Challenges of Transplantation

Currently, the standard method of organ preservation is Static Cold Storage (SCS). This involves rapid flushing of the graft after removal, followed by immersion of the organ in a dedicated preservation fluid and maintenance of the organ in hypothermic conditions using ice. The organ thus preserved can be transported from the donor centre to the transplant centre, trying to maintain hypothermic conditions.
In both static storage and transport, it is essential to ensure homogeneous temperature conditions and stability of the organ, in order to avoid damage due to thermal changes, and mechanical or other damage.

Target conditions: Static preservation, Abnormal transport conditions
Designated System: PerTravel®

With the increasing scarcity of suitable organs available for transplantation, it was necessary to expand the selection criteria, with the aim of increasing the donor pool. In this regard, so-called ‘marginal’ organs are also taken into account, i.e. those obtained from elderly donors, donors with comorbidities or ‘non heart beating’ donors (DCD), which in the past were usually discarded because they were damaged by complex biological reactions. Many of these organs can be transplanted if their quality, safety and functionality are ensured. Therefore, restoring and maintaining organ viability with a dynamic preservation technique is a fundamental prerequisite for the proper use of even marginal organs in order to increase their availability for transplantation.

In addition, these organs are aggravated by Ischemia-Reperfusion Injury (IRI), which remains an important risk factor for ‘marginal organs’, limiting the success of the transplant and the survival of the organ and/or the recipient, both immediately postoperatively and in the long term. Specifically, ‘ischaemia’ represents a lack of blood supply that results in a shortage of oxygen and glucose, which are necessary for cell and tissue survival. At the cellular level, ischaemia leads to anaerobic metabolism and various mechanisms are activated that lead to cell death. In parallel, a build-up of toxic substances (cytokines, complement system) occurs, leading to high cell toxicity.

The restoration of blood flow (reperfusion) to the ischaemic tissue results in a supply of oxygen and nutrients to the tissue and cells damaged by ischaemia. On the other hand, this results in the release of toxic substances accumulated during the no-flow period, which attract further pro-inflammatory substances, amplifying and exacerbating the ischaemic damage. The use of ex-situ organ perfusion systems is a key aspect of increasing the number, quality and safety of solid organ transplants.

Target Conditions: Ischemia-Reperfusion Injury, Dynamic Preservation
Designated Systems: PerLife®, PerSorb®, PerLungs®

Therapeutic systemsdedicated to Transplantation