For the past few years, stem cells have come out on top as a reliable solution to many health concerns, from diabetes to cancer. Clinical stage BioTech company Cynata Therapeutics (ASX: CYP) has been testing stem cell therapy for kidney transplant patients. The Company announced that Leiden University Medical Center (LUMC) is funding an important clinical trial to investigate Cynata’s Cymerus™ mesenchymal stem cells (MSCs) as a treatment for renal graft rejection during kidney transplants. It aims to use stem cells to, hopefully, reduce the need for anti-rejection meds.
The clinical trial, dubbed the “Safety and Efficacy of iPSC-derived Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients – the Nereid Study”, will be led by Professor Ton Rabelink, Head of the Department of Internal Medicine of LUMC. It 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.
Professor Rabelink shared, “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.”
Currently, lifelong immune suppressive therapy is required in kidney transplant patients to reduce the risk of their body rejecting the transplant. This can lead to increased risk of infections and cancer and the main anti-rejection drugs can also be toxic. MSCs, which are typically found in bone marrow, placenta and umbilical cord, can help fight it, as per Cynata’s research.
The trial will be an open label, non-randomized, non-blinded, prospective, single centre clinical phase Ib study. It will be conducted on recipients aged 18-75 years old. The principal investigator is Dr. HS Spijker, Department of Nephrology, LUMC. After their transplant surgery, patients will receive a drug used to treat graft rejection. Then, six to seven weeks later, they will receive two doses of Cymerus MSCs followed by withdrawal of anti-rejection medication.
Uptil now, the study has found that mesenchymal stromal/stem cells can possibly enable the early withdrawal of anti-rejection drugs in renal transplant recipients without increased rejection and with preserved renal function.
Cynata’s Chief Executive Officer, Dr Ross Macdonald, commented, “This exciting new collaboration follows very promising clinical trial data with MSCs published by Professor Rabelink1 and our own published pre-clinical data 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.”
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