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NeuroScientific Biopharmaceuticals Reports Positive Outcomes from StemSmart(TM) MSC Therapy in Renal Transplantation

Jane Morgan Management

NeuroScientific Biopharmaceuticals Reports Positive Outcomes from StemSmart™ MSC Therapy in Renal Transplantation

Sydney, Australia – 27 August 2025 – NeuroScientific Biopharmaceuticals Ltd (ASX:NSB) today announced promising results from two clinical studies evaluating its proprietary StemSmart™ mesenchymal stromal cell (MSC) therapy in renal transplantation. The findings provide strong support for further clinical development aimed at improving outcomes in kidney transplant patients.

StemSmart™ MSC and Renal Transplantation

  • StemSmart™ MSC therapy shows promising results in two early studies in renal transplantation. 

  • Both studies support further clinical development and the potential of StemSmart™ MSC in both preventing and treating graft failure and rejection. 

  • A case series of 10 adult patients with treatment-refractory acute renal rejection following renal transplantation were treated with StemSmart™ MSC on compassionate grounds, as a salvage and adjunctive therapy. These patients were facing the loss of their donor kidney. 

  • Importantly, positive clinical outcomes from the use of StemSmart™ MSC therapy were observed. 

  • 8 out of 10 patients retained their kidney following the StemSmart™ MSC infusion. 

  • A second study was undertaken in 12 adults undergoing deceased-donor renal transplantation, to assess if StemSmart™ MSC therapy was safe and could be tolerated, to potentially alleviate ischaemia-reperfusion injury of transplantation. 

  • Ischaemia-reperfusion injury occurs when blood circulation is re-established to the kidney during the transplantation procedure and can result in delayed functioning of the kidney and an increased risk of graft rejection and loss. It is particularly relevant in deceased-donor kidney transplantation. 

  • The study demonstrated that StemSmart™ MSC infusion was well tolerated and safe in patients undergoing renal transplantation, with no infusion related toxicities (Appendix 2). Although the study was not designed to determine efficacy, results were encouraging for an improvement in delayed graft function immediately post transplantation and kidney graft function was excellent at 3 months and 12 months. 

Dr Marian Sturm, Chief Scientific Advisor commented:
“Resolution of acute rejection in the majority of the small group of patients facing loss of their kidney was fantastic. 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 of StemSmart™ MSC at the time of kidney transplantation was demonstrated in the second study. The study demonstrated that using StemSmart™ MSC therapy early in the transplantation process has the potential to mitigate the kidney damage associated with the transplant procedure and would be a major advancement for deceased-donor renal transplantation.”

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About NeuroScientific Biopharmaceuticals Ltd 

NeuroScientific Biopharmaceuticals Limited (ASX: NSB) is a biotechnology company focused on the development of novel therapeutics targeting immune-mediated inflammatory disorders. The Company’s research is centred on modulating pathological immune responses involved in chronic and degenerative conditions, particularly where current therapeutic options demonstrate limited efficacy or durability. NSB applies advanced preclinical and translational strategies to support the development of first-inclass or best-in-class biologics addressing significant unmet clinical need.


Contact details:

Jane Morgan
Jane Morgan Management
Investor & Media Relations
[email protected]

Attachments

6A1280368_NSB.pdf

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