NeuroScientific Biopharmaceuticals has delivered another promising set of patient outcomes from its StemSmart stem cell therapy, reporting that four of the five patients treated for fistulising Crohn’s disease under its Special Access Program demonstrated a clinical response.
All five patients showed improvement following treatment, with no serious adverse events recorded, marking a strong outcome in a group typically resistant to conventional therapies.
The results build on earlier data released in January, when NeuroScientific reported that three of four patients had achieved a clinical response and a fourth had shown a partial response, significantly extending the company’s real-world evidence base for its StemSmart therapy.
A clinical response in this context is defined as either the closure of at least 50 per cent of fistula openings or a reduction of at least 50 per cent in fistula discharge, as assessed by treating physicians or qualified investigators.
Management says all patients also recorded improvements across established Crohn’s disease scoring systems, while early MRI imaging indicated a trend towards fistula healing, although it was still too early to assess full closure.
Importantly, all patients had at least one seton - a small surgical drain used to help control infection and drainage in a fistula - removed, which can be a meaningful sign of healing, while the treatment was reported to be safe and well tolerated.
NeuroScientific Biopharmaceuticals chief medical officer Dr Cathy Cole said: “A clinical response rate of 80% to a novel treatment for a serious, debilitating and long-standing medical condition, that largely affects younger adults, is exceptional. We can confidently proceed to our phase 2 trials informed on frequency and timing of doses of MSC and MRI assessments. In keeping with our total experience to date, there are no safety concerns.”
Fistulising Crohn’s disease is one of the most severe complications of inflammatory bowel disease and can leave patients with limited treatment options after existing therapies fail or lose effectiveness over time.
StemSmart is based on mesenchymal stem cells derived from adult donor bone marrow and is designed to regulate immune responses and reduce inflammation rather than simply mask symptoms.
In simple terms, mesenchymal stem cells are early repair cells that can help calm damaging inflammation and support healing in injured tissue, which is why NeuroScientific believes they may be useful in hard-to-treat Crohn’s disease.
Importantly, the latest outcomes will now help shape NeuroScientific’s planned phase two clinical trial in fistulising Crohn’s disease, which is expected to begin in Australia in the second half of this year.
The upcoming program is set to run alongside a broader phase two study in refractory Crohn’s disease across Australia and the United States.
In parallel, the company has also been progressing its manufacturing scale-up of StemSmart, including transferring its production process to Brisbane-based cell therapy manufacturer Q-Gen to support future trial supply and longer-term commercial ambitions.
With patient outcomes continuing to improve and clinical and manufacturing work gathering pace, NeuroScientific is steadily building the case for its StemSmart therapy as a potential new treatment option in a market where unmet need remains high.
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By Doug Bright
