Biotech innovator NeuroScientific Biopharmaceuticals has received the green light from Australia’s drugs regulator to treat its first three patients with Crohn’s disease using its proprietary “StemSmart” stem cell therapy. The approval marks a pivotal milestone in the company’s special access program and paves the way for a planned phase two clinical trial targeting those that don’t already respond to existing treatments next year.
NeuroScientific Biopharmaceuticals has notched a major regulatory milestone after securing approval from Australia’s Therapeutic Goods Administration (TGA) to treat patients affected with severe Crohn’s disease with its proprietorial stem cell therapy.
Stem cell therapies have long promised to press the body’s reset button - potentially reversing injuries and damage from disease, regenerating tissue and reshaping modern medicine.
Crohn’s disease is a painful autoimmune gut condition that can turn lives upside down. However, long-suffering patients may just be starting to see a light at the end of what has been a very long and dark tunnel. For the first time, NeuroScientific’s patented stem cell therapy, dubbed “StemSmart”, will be given to the first group of patients under the TGA’s special access scheme category B pathway.
That route allows doctors to treat patients with unapproved drugs on a case-by-case basis, subject to clinical justification.
StemSmart’s cells are harvested from adult human bone marrow, where special stem cells are isolated, grown and processed using a unique method to boost their effectiveness.
NeuroScientific Biopharmaceuticals chief executive officer Nathan Smith said: “I am extremely excited with the TGA approval to treat patients with StemSmart as we advance the special access program towards completion by mid-2026. This milestone, alongside our progress in transferring the manufacturing technology to Q-Gen in parallel, paves the way towards initiation of our Phase 2 clinical trial next year.”
The recent move follows NeuroScientific’s $5.1 million acquisition of unlisted Perth-based stem cell therapy company Isopogen, earlier this year.
After closing the deal, the company moved quickly to transfer its technology to Queensland-based Q-Gen Cell Therapeutics, with the handover currently on track.
Q-Gen has now taken over manufacturing StemSmart’s specialised stem cells from Royal Perth Hospital’s Cell and Tissue Centre as a key step towards scaling up production and paving the way for future commercial use.
NeuroScientific says more patients will receive stem cell therapy as new clinical applications get rolled out. The products will come from the East Metropolitan Health Service in Perth, which is already TGA-certified, or from Isopogen’s Queensland manufacturer once it gains final approval.
Beyond Crohn’s disease, NeuroScientific sees significant global potential for its StemSmart platform. The company is eyeing markets worth US$13.8 billion for Crohn’s by 2026, US$7.2 billion for kidney transplants by 2030, a massive US$33 billion lung disorder market by 2034 and US$5.31 billion for Graft-versus-host disease GvHD by 2032
With the first cohort of patients approved, manufacturing scale-up underway and Phase 2 planning locked in for 2026, NeuroScientific appears to be positioning StemSmart as a potential first-in-class therapy for patients with limited treatment options.
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