• Cynata to collaborate with Leiden University Medical Center (LUMC) in the Netherlands, in a new clinical trial in patients who have received a kidney transplant
• Trial to be funded by LUMC; Cynata will supply iPSC-derived Cymerus mesenchymal stem cells (MSCs) at its cost to facilitate the trial and has full commercial rights
• There are approximately 130,000 kidney transplants around the world each year. Kidney transplantation is life-saving in patients with chronic renal failure and frees the patient from the need for dialysis.
• Currently, lifelong immune suppressive therapy is required in renal transplant patients to reduce the risk of rejection. This can lead to increased risk of infections and cancer and the main anti-rejection drugs are also directly toxic to the kidneys
• In previous clinical trials, mesenchymal stromal/stem cells have shown potential to enable the early withdrawal of anti-rejection drugs in renal transplant recipients without increased rejection and with preserved renal function

The clinical trial, entitled the "Safety and Efficacy of iPSC-derived Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients - the Nereid Study", will be led by Prof. Ton Rabelink, Head of the Department of Internal Medicine of LUMC and will seek to recruit 10 patients who have undergone a renal transplant. The trial is expected to commence in 2023, pending receipt of customary and relevant regulatory, ethics and administrative approvals.

Dr Ross Macdonald, Cynata's Chief Executive Officer, said:

"This exciting new collaboration follows very promising clinical trial data with MSCs published by Professor Rabelink^[1] and our own published pre-clinical data^[2] in organ transplant rejection. The potential to enhance survival of transplanted donor organs while at the same time reducing or eliminating the need for damaging anti-rejection drugs would be a substantial breakthrough in transplantation medicine. We are delighted to be working with one of Europe's leading transplant centres and with Professor Rabelink and his team to conduct this important clinical trial."

Professor Rabelink said:

"There is an urgent need for more effective management of immune rejection of donor organs while preserving organ function and minimizing side effects of anti-rejection therapy. From this perspective, MSC therapy is of interest and our own clinical studies have provided strong support for MSC treatment to substantially advance the field of transplantation medicine. The consistency and potency of Cynata's unique iPSC-derived Cymerus MSCs make them an ideal candidate for this clinical trial."