NeuroScientific Biopharmaceuticals (ASX:NSB) has reported encouraging results from two early studies of its StemSmart mesenchymal stromal cell (MSC) therapy in renal transplantation, reinforcing its potential to improve outcomes for patients facing the risks of graft rejection and transplant-related complications.
The company, which acquired Isopogen WA earlier this year, has been reviewing historical data on StemSmart MSC and is now preparing for further clinical development. The therapy harnesses the anti-inflammatory and immunomodulatory properties of MSCs, aiming to both treat acute rejection and mitigate damage caused during the transplant procedure itself.
One case series involved 10 adult patients with treatment-refractory acute renal rejection who had exhausted conventional options and were at risk of losing their donor kidney. Treated on compassionate grounds, these patients received weekly infusions of StemSmart MSC over a four-week period. Eight of the ten patients retained their kidney, with biopsies showing reduced inflammatory cell invasion, stabilised renal function, and in some cases, clearance of donor-specific antibodies. Infusions were well tolerated, with no treatment-related toxicities reported.
A second Phase 1 pilot study tested StemSmart MSC in 12 adults undergoing deceased-donor renal transplantation, with infusions administered within 12 hours of reperfusion and again at seven days. This trial sought to address ischaemia-reperfusion injury, a complication that arises when blood supply is restored to a transplanted kidney after storage, often leading to delayed graft function and higher rejection risk. The treatment was found to be safe and well-tolerated, with no infusion-related toxicities or infections observed. Only two patients required limited post-operative dialysis, while kidney function was reported as excellent at both three and twelve months.
Dr Marian Sturm, NeuroScientific’s Chief Scientific Advisor, said the results underline the potential of MSC therapy to transform transplant outcomes. “Resolution of acute rejection in the majority of the small group of patients facing loss of their kidney was fantastic,” she said. “The anti-inflammatory and immunomodulatory properties of StemSmart™ MSC brought the inflammatory cell invasion of their kidney under control and resulted in a stabilisation of renal function. Additionally, the safety and tolerability of administration at the time of transplantation demonstrates that StemSmart™ MSC has the potential to mitigate transplant-associated kidney damage — a major advance for deceased-donor renal transplantation.”
The findings are particularly significant given the challenges of renal transplantation. Despite advances in immunosuppressive therapy, many patients still experience acute rejection, delayed graft function or long-term graft failure. Ischaemia-reperfusion injury remains a common and serious complication, especially in kidneys sourced from deceased donors, which are often subject to longer cold storage times. By dampening inflammation and improving graft survival, StemSmart MSC could address a significant unmet need in the field.
Beyond renal transplantation, NeuroScientific has also identified several therapeutic areas where StemSmart MSC could be applied. These include Crohn’s disease, graft-versus-host disease, and lung disorders. With such breadth of potential applications, the company sees MSC therapy as a versatile platform with significant commercial upside.
While the studies reported so far have involved small patient numbers, they provide a compelling foundation for further trials. NeuroScientific is expected to pursue expanded clinical development, building on both the compassionate-use data in acute rejection and the pilot study in transplant safety.
The company says these early outcomes reinforce its confidence in StemSmart MSC as both a treatment for graft failure and a preventative therapy to improve transplant success rates. For patients facing the devastating prospect of losing a kidney transplant, such innovation could represent not only a scientific advance but a profound improvement in quality of life.