Four Patients Now Treated Under StemSmart™ Special Access Program
NeuroScientific Biopharmaceuticals has initiated treatment of its fourth patient under the Special Access Scheme for StemSmart™, progressing towards a Phase 2 trial targeting severe Crohn’s disease.
- Fourth patient treated under Special Access Scheme for StemSmart™
- Real-world data to inform Phase 2 clinical trial design in 2026
- Focus on treatment-resistant fistulising Crohn’s disease
- Manufacturing and regulatory preparations underway
- StemSmart™ platform has broader immune disease potential
Clinical Progress in Challenging Crohn’s Disease
NeuroScientific Biopharmaceuticals Limited (ASX, NSB) has announced a significant milestone in its clinical development program with the commencement of treatment for the fourth patient under Australia’s Special Access Scheme (SAS) using its StemSmart™ mesenchymal stem cell therapy. This therapy targets fistulising Crohn’s disease, a severe and treatment-resistant form of the chronic inflammatory bowel condition.
The Special Access Scheme Category B pathway allows patients who have exhausted conventional treatment options to access unapproved therapies under regulatory oversight. NeuroScientific’s use of this pathway not only provides urgent therapeutic intervention for these patients but also generates valuable real-world clinical data. This data is expected to directly inform the design and execution of the company’s planned Phase 2 clinical trial, anticipated to begin in the second half of 2026.
StemSmart™, A Platform with Broad Potential
StemSmart™ is derived from adult human donor bone marrow mesenchymal stem cells enhanced through a patented manufacturing process to boost therapeutic activity. Early indications from prior Phase 2 studies suggest the therapy is both potent and safe, with compassionate use cases already reporting positive outcomes in severe, treatment-resistant patients.
Beyond Crohn’s disease, NeuroScientific envisions StemSmart™ as a versatile platform with potential applications in organ transplant immune tolerance, lung inflammatory diseases, and graft-versus-host disease. These indications represent substantial global markets, underscoring the commercial upside if clinical development proceeds successfully.
Manufacturing and Regulatory Momentum
To support the upcoming Phase 2 trial, the company is actively advancing manufacturing technology transfer and regulatory planning. Production is coordinated through TGA-certified facilities including East Metropolitan Health Service and the Queensland Institute of Medical Research, ensuring quality assurance and supply readiness.
NeuroScientific’s CEO Nathan Smith highlighted the importance of this progress, noting that the ongoing patient treatments under the Special Access Program mark meaningful advancement for both patients and clinicians in a field with limited effective therapies. The company remains focused on generating robust clinical insights to de-risk and optimize its Phase 2 trial design.
Looking Ahead
Results from the initial round of patient treatments are expected in January 2026, providing an early glimpse into StemSmart™’s clinical impact. These findings will be critical in shaping the next phase of development and regulatory engagement, with the ultimate goal of delivering a novel therapeutic option for patients suffering from refractory Crohn’s disease.
Bottom Line?
As NeuroScientific moves closer to its Phase 2 trial, upcoming patient data will be pivotal in validating StemSmart™’s promise in a challenging therapeutic area.
Questions in the middle?
- What clinical outcomes will the initial patient treatments reveal in January 2026?
- How will manufacturing scale-up impact trial timelines and commercial readiness?
- What regulatory hurdles remain before broader approval and reimbursement?
