Perth-based NeuroScientific Biopharmaceuticals has appointed leading Australian clinical research organisation (CRO) Southern Star Research to manage its planned phase two clinical trial for refractory Crohn’s disease in Australia and the United States.
The appointment is a key operational milestone in the company’s push to evaluate its patented “StemSmart” stem cell technology, with trials slated to start by the end of the year.
Refractory Crohn’s disease and, in particular, fistulising Crohn’s, where ulcerations can develop into abnormal tunnels connecting the bowel with other organs or the skin, are both notoriously difficult to treat.
Neuroscientific's innovative StemSmart therapy uses a specialised class of mesenchymal stem cells (MSC's), prepared as a simple intravenous infusion. These cells are harvested from adult donor bone marrow and then run through a patented refinement process designed to dial up their therapeutic punch and improve clinical outcomes.
Better still, mesenchymal stem cells are universal donor cells, meaning no donor-recipient matching and no waiting lists. In practical terms, StemSmart is shaping up as a genuine off-the-shelf cell therapy.
Southern Star Research, one of Australia's leading CRO's, will be responsible for identifying, setting up and managing clinical sites for the trial, engaging with clinicians and principal investigators and coordinating the logistics of delivering NeuroScientific’s StemSmart product to enrolled patients. The company has a strong pedigree, having recently been named best CRO in Australia at the 2026 Asia-Pacific Bioprocessing Excellence Awards.
The move follows the company’s successful engagement with the all-powerful US Food & Drug Administration (FDA), where it held a crucial meeting in August to gain feedback on its planned trial. Today’s appointment of a CRO demonstrates the company is now executing on its stated plan to enter the lucrative US market.
The appointment marks NeuroScientific's next step into a significant and expanding field. The global market for Crohn’s disease therapies is already valued at around US$13 (A$18.7) billion and is forecast to see steady growth over the next decade, underlining the commercial relevance of new solutions. Notably, stem cell programs for Crohn’s are gaining serious momentum, with multiple clinical trials underway globally, signalling sustained scientific and commercial interest in the space.
NeuroScientific Biopharmaceuticals chief executive officer Nathan Smith said: “We are delighted to appoint Southern Star Research to deliver StemSmart to patients suffering from treatment-resistant Crohn's disease. Southern Star Research's capabilities are a strong fit for our program as we progress towards clinical site start-up and engagement with principal investigators."
The company’s confidence to push into a major phase two study is underpinned by highly encouraging results from a previous Special Access Program (SAP) trial in fistulising Crohn's. Importantly, all five patients in that study showed improvement following treatment, with no serious adverse events recorded, a strong outcome in a group typically resistant to conventional therapies.
The focus on Crohn’s disease represents a significant strategic pivot for NeuroScientific, which spent years developing its “EmtinB” peptide for neurodegenerative conditions such as Alzheimer’s disease. However, after acquiring the StemSmart technology platform in mid-2025, the company rapidly reoriented its focus.
The clinical need for new treatments for difficult-to-treat patient subsets remains high, a fact underscored by recent positive results from Johnson & Johnson in perianal fistulising Crohn’s disease, highlighting the considerable big-pharma firepower now being trained on the toughest end of the Crohn’s treatment spectrum.
With promising early data from its SAP trial, a clear regulatory pathway being forged with the FDA, and now a leading CRO on board, NeuroScientific appears to be ticking all the right boxes as it advances its StemSmart technology towards a pivotal international trial.
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By Murray Ward
