Promising Results from StemSmart Therapy for Fistulising Crohn’s Disease
NeuroScientific Biopharmaceuticals has released another set of positive patient outcomes from its StemSmart stem cell therapy, highlighting a clinical response in four out of five patients treated for fistulising Crohn’s disease under its Special Access Program. The results show that all five patients experienced some level of improvement, with no serious adverse events reported. This is particularly significant given the challenges associated with treating this condition, which often proves resistant to conventional therapies.
The data builds on earlier findings from January, where three out of four patients showed a clinical response and one demonstrated a partial response. These results have significantly expanded the real-world evidence base for StemSmart, reinforcing the company’s confidence in proceeding to phase 2 trials.
A clinical response, as defined by the company, includes either the closure of at least 50% of fistula openings or a reduction of at least 50% in fistula discharge, as assessed by treating physicians or qualified investigators. Dr Cathy Cole, chief medical officer at NeuroScientific Biopharmaceuticals, stated:
“We can confidently proceed to our phase 2 trials.”
Clinical Improvements and Safety Profile
All patients also recorded improvements across established Crohn’s disease scoring systems, while early MRI imaging suggested a trend towards fistula healing. However, full closure was still too early to assess. Importantly, all patients had at least one seton—small surgical drains used to manage infection and drainage—removed, which is considered a meaningful sign of healing. The treatment was also reported to be safe and well tolerated.
Dr Cole added:
“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.”
Understanding Fistulising Crohn’s Disease
Fistulising Crohn’s disease is one of the most severe complications of inflammatory bowel disease. It often leaves patients with limited treatment options after existing therapies fail or lose effectiveness over time. StemSmart, based on mesenchymal stem cells derived from adult donor bone marrow, aims to regulate immune responses and reduce inflammation rather than simply masking symptoms.
In simple terms, mesenchymal stem cells are early repair cells that can help calm damaging inflammation and support healing in injured tissue. This is why NeuroScientific believes they may be useful in hard-to-treat Crohn’s disease.
Future Trials and Manufacturing Developments
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 will run alongside a broader phase two study in refractory Crohn’s disease across Australia and the United States.
In parallel, the company has been progressing its manufacturing scale-up of StemSmart, including transferring its production process to Brisbane-based cell therapy manufacturer Q-Gen. This move is intended to support future trial supply and longer-term commercial ambitions.
Building a Case for StemSmart
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.
