8 of 10 Patients Retain Kidney After StemSmart™ MSC Treatment in Early Study

Promising Clinical Advances in Renal Transplantation

NeuroScientific Biopharmaceuticals Ltd (ASX – NSB) has unveiled compelling early clinical data for its StemSmart™ mesenchymal stromal cell (MSC) therapy in renal transplantation. The announcement highlights two small but significant studies that demonstrate the therapy’s potential to both rescue failing kidney grafts and improve outcomes following deceased-donor transplants.

The first study involved a compassionate use case series of 10 adult patients suffering from treatment-refractory acute renal rejection, a condition that typically leads to loss of the transplanted kidney. Remarkably, 8 of these patients retained their grafts following weekly intravenous infusions of StemSmart™ MSC over four weeks. Biopsies confirmed a reduction in inflammatory cells and stabilization of kidney function, underscoring the therapy’s immunomodulatory and anti-inflammatory properties.

Safety and Early Efficacy Signals in Deceased-Donor Transplants

The second study was a phase 1 pilot involving 12 adults receiving deceased-donor kidney transplants. StemSmart™ MSC was administered shortly after reperfusion and again seven days later to mitigate ischaemia-reperfusion injury, a common complication that can impair graft function. The therapy was well tolerated with no infusion-related toxicities. Encouragingly, only two patients required dialysis post-operation, and kidney function at 3 and 12 months was excellent, suggesting a protective effect against delayed graft function.

Dr Marian Sturm, Chief Scientific Advisor at NeuroScientific, emphasized the significance of these findings – "The resolution of acute rejection in most patients facing imminent graft loss is fantastic. Using StemSmart™ MSC early in transplantation could be a major advancement, potentially reducing kidney damage and improving long-term outcomes."

Market Potential and Next Steps

Kidney transplantation remains the gold standard treatment for end-stage renal disease, yet graft rejection and injury continue to limit success. The global market for organ transplant immunosuppressants is projected to reach US$7.2 billion by 2030, with renal transplantation comprising the majority. StemSmart™ MSC’s dual ability to modulate immune response and reduce inflammatory injury positions it well to address these unmet needs.

While the studies involve limited patient numbers and are preliminary, they provide a strong rationale for advancing StemSmart™ MSC through larger clinical trials. NeuroScientific’s ongoing review of historical data and its acquisition of Isopogen WA Ltd underpin a strategic push to develop this therapy further.

Investors and clinicians alike will be watching closely as NeuroScientific progresses StemSmart™ MSC, potentially transforming the landscape of renal transplantation treatment.