NeuroScientific Biopharmaceuticals has reached another clinical milestone, with a fourth Crohn’s disease patient now receiving its patented StemSmart stem cell therapy for the chronic bowel disease under Australia’s Special Access Scheme. The company says data from the real-world program will directly inform the design of its upcoming phase two trial, slated to begin in the second half of 2026.
NeuroScientific Biopharmaceuticals has medicated a fourth fistulising Crohn’s disease patient with its unique “StemSmart” stem-cell therapy, in a key step forward for the company’s game-changing treatment of the debilitating bowel condition.
Approvals have already been secured to provide the unapproved therapy using the Therapeutic Goods Administration’s (TGA) special access scheme.
Under a particular carve-out provision of the program, patients who failed to respond to the standard therapies and are still affected by a severe or treatment-resistant form of the disease can now receive NeuroScientific’s promising treatment.
For these patients - often left with limited or no effective treatments - StemSmart represents fresh hope. The innovative therapy involves preparing a specific type of stem cell known as “mesenchymal” stem cells (MSC) - for use as an intravenous infusion.
The cells are first harvested from adult human donor bone marrow before being refined through a patented process designed to improve their therapeutic potency and clinical response.
Adding to the promising credentials of the therapy, MSC are universal donor cells, which means there is no need for matching between a donor and recipient. They are effectively an “off-the shelf” cell therapy.
NeuroScientific Biopharmaceuticals chief executive officer Nathan Smith said: “We believe StemSmart has the potential to offer a new therapeutic option in an area where there are limited effective treatments. A prior phase two study in refractory Crohn’s disease indicated the therapy was potent, efficacious and safe, while several compassionate-access patients have reported clinical improvements in cases previously unresponsive to standard treatments.”
All four patients in the company’s first treatment cohort are living with an aggressive and debilitating form of fistulising Crohn’s disease. Management says the data generated from their treatments will therefore deliver valuable insights for the design of NeuroScientific’s upcoming phase two trial, slated to begin in 2026. The study is also set to sharpen the company’s commercial edge, paving the way for a broader rollout of its unique therapy.
Beyond Crohn’s disease, the company sees big potential in treating organ transplant rejection, lung inflammation and graft-versus-host disease, which, when combined, are worth tens of billions of dollars worldwide.
According to global research cited by NeuroScientific, the Crohn’s disease therapeutics market is forecast to reach US$13.8 billion (A$21b) by 2026, while related segments such as lung disorders and graft-versus-host disease could grow to US$33b (A$50b) and US$5.3b (A$8b) respectively.
More patients are set to receive StemSmart treatment as fresh doses come online. The first batches will be released from Perth’s East Metropolitan Health Service once they clear final quality checks, while Isopogen’s partner at the Queensland Institute of Medical Research stands ready to ramp up production once its certification is locked in.
NeuroScientific’s broader pipeline of products also includes a protein-based compound called “EmtinB”, which is designed to latch onto specific cell receptors. Once the compound connects, it sparks a chain of signals inside the cell that promote healing, nerve growth and reduce inflammation.
Modelled on a natural human protein called Metallothionein-IIA, EmtinB mimics the body’s own defence system. The company says the early tests have been promising, showing it is safe, precise and well tolerated even at high doses.
With four patients now on treatment, the first round of clinical results is expected in January 2026. If the outcomes are favourable, they could propel NeuroScientific into its next major growth phase - moving from early access treatments to formalised trials aimed at bringing a new class of stem-cell therapy closer to market.
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