NeuroScientific Biopharmaceuticals has appointed Southern Star Research to manage its planned phase two Crohn’s disease trial in Australia and the United States, as the Perth-based company prepares to begin testing its StemSmart cell therapy by the end of the year.
The study will focus on patients with refractory Crohn’s disease, including fistulising Crohn’s, a severe form in which ulcers can develop into abnormal tunnels linking the bowel with other organs or the skin.
Southern Star Research will identify and establish clinical sites, work with clinicians and principal investigators, and coordinate the delivery of StemSmart to enrolled patients. The Australian clinical research organisation was named the country’s best contract research organisation at the 2026 Asia-Pacific Bioprocessing Excellence Awards.
StemSmart uses mesenchymal stem cells taken from adult donor bone marrow. NeuroScientific says its patented refinement process is designed to enhance the cells’ therapeutic potential before they are administered through an intravenous infusion.
The cells are universal donor cells, meaning the treatment does not require donor-recipient matching. The approach is therefore being developed as an off-the-shelf cell therapy.
The appointment follows a meeting with the United States Food and Drug Administration in August, during which NeuroScientific received feedback on its proposed trial. The company said engaging a clinical research organisation marked the next step in its plans to enter the US market.
Chief executive Nathan Smith said the appointment was “a key operational milestone towards the initiation of the Phase 2 clinical trial by the end of CY2026”.
He added: “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.”
NeuroScientific’s decision to proceed with a phase two study follows results from an earlier Special Access Program trial involving five patients with fistulising Crohn’s disease. All five were reported to have improved after treatment, with no serious adverse events recorded.
The company shifted its focus towards Crohn’s disease after acquiring the StemSmart platform in mid-2025. It had previously spent years developing its EmtinB peptide for neurodegenerative diseases including Alzheimer’s disease.
The global Crohn’s disease therapies market is valued at about US$13 billion, or A$18.7 billion, and is forecast to grow over the next decade. Several stem cell programmes for Crohn’s disease are also undergoing clinical trials around the world.
