NeuroScientific’s StemSmart™ Delivers Promising Real-World Results in Crohn’s Disease Trial

NeuroScientific Biopharmaceuticals (ASX: NSB) has chalked up a major clinical milestone, with the company announcing successful outcomes from its Special Access Program treating patients with fistulising Crohn’s disease using its proprietary StemSmart™ cell therapy.

In results released to the ASX on 13 January 2026, three out of four patients in the first treatment cohort experienced a successful Clinical Response after receiving StemSmart™, while the fourth showed a partial response and clinical improvement. These outcomes, achieved in a real-world setting, provide critical early validation for NSB’s platform and represent a potential breakthrough for patients with one of the most stubborn complications of inflammatory bowel disease.

A Tough Condition Meets a Novel Therapy

Fistulising Crohn’s disease is a particularly debilitating manifestation of inflammatory bowel disease, often resistant to current therapies. NSB’s StemSmart™, a mesenchymal stem cell (MSC) product derived from adult bone marrow and produced via a patented manufacturing process, was administered under the Therapeutic Goods Administration’s (TGA) Special Access Scheme (SAS) Category B — a regulatory route reserved for patients with limited or no other options.

A Clinical Response was defined as either the closure of at least 50% of fistula openings or a ≥50% decrease in discharge, as assessed by the treating physician. By that measure, the treatment cleared the bar in three of the four patients, with the fourth still showing signs of benefit and undergoing further assessment.

Management Weighs In

NSB CEO Nathan Smith was quick to frame the results as both a medical and strategic win:

“These treatment results provide critical validation of the StemSmart™ MSC platform in presenting a potential therapeutic solution to patients with debilitating fistulising Crohn’s disease… These early outcomes allow us to advance the development of a novel therapeutic in a responsible, informed, and patient-centred fashion”.

Chief Medical Officer Dr Cathy Cole was similarly buoyed by the findings, calling the response “exceptional,” especially given the severity and chronic nature of the condition in these patients. She added:

“The response to treatment is truly outstanding and offers hope for clinical recovery when there was previously little”.

From Access to Acceleration

While the current results stem from a limited cohort, they will feed directly into the design of NSB’s planned Phase 2 clinical program, set to begin in the second half of 2026. That trial will expand the scope to refractory Crohn’s disease more broadly and is slated to run across both Australia and the United States.

Startup activities are already underway, including tech transfer for commercial manufacturing and detailed regulatory planning. The company intends to use this Phase 2 trial to support future commercialisation and reimbursement strategies.

A Multi-Billion Dollar Target Market

NSB is positioning StemSmart™ not just for Crohn’s disease, but as a platform cell therapy for a range of chronic inflammatory conditions. The addressable markets are eye-watering:

• Crohn’s Disease: US$13.8 billion by 2026

• Kidney Transplant (immune tolerance): US$7.2 billion by 2030

• Lung Disorders: US$33 billion by 2034

• Graft-vs-Host Disease (GvHD): US$5.31 billion by 2032

These numbers highlight the commercial runway available if NSB can replicate these early results in larger, controlled trials.

The Bottom Line

While early-stage and based on a small cohort, these results give NeuroScientific more than just momentum — they provide a clear signal that StemSmart™ may offer meaningful clinical benefit where current therapies have failed. With a Phase 2 trial in the works and global commercial markets in view, 2026 could be a defining year for this quietly advancing biotech.