NeuroScientific Biopharmaceuticals Ltd (NSB) has achieved remarkable results from its Special Access Program using its patented StemSmartâ„¢ therapy. This program targeted patients with fistulising Crohn's disease, a severe condition often resistant to conventional treatments. The therapy involved mesenchymal stem cells (MSCs) derived from adult human donor bone marrow, and 80% of patients achieved a successful clinical response, demonstrating significant improvement without serious adverse events. Supported by recognized Crohn's disease scoring systems, these results pave the way for a Phase 2 clinical trial in Australia, anticipated to begin in the second half of CY2026. NSB aims to obtain regulatory approval, targeting the global Crohn's disease market, valued at $13.8 billion by 2026, and address other conditions like kidney transplant, lung disorders, and graft-versus-host disease (GvHD).
Key Points
NSB reported remarkable clinical results from its Special Access Program using StemSmartâ„¢.
80% of patients with fistulising Crohn's disease achieved a successful clinical response.
StemSmartâ„¢ demonstrated safety and efficacy in patients resistant to conventional treatments.
The therapy involves mesenchymal stem cells derived from adult human donor bone marrow.
NSB plans a Phase 2 clinical trial for fistulising Crohn's disease in Australia in 2H CY2026.
StemSmartâ„¢ targets a global market valued at US$13.8 billion by 2026 for Crohn's Disease.
NSB's broader strategy includes obtaining regulatory and reimbursement approval for MSC therapy.
No serious adverse events were observed during the Special Access Program.
The clinical response was supported by internationally recognized scoring systems for Crohn's disease.
StemSmartâ„¢ also aims to address unmet needs in kidney transplant, lung disorders, and GvHD.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.