NeuroScientific Biopharmaceuticals (ASX: NSB) is investigating the use of its newly-acquired StemSmart stem cell technology for complex indications including refractory Crohn’s disease and steroid-refractory GVHD (graft-versus-host disease).

The company recently finalised the acquisition of Isopogen WA, which developed the patented technology for the manufacture of mesenchymal stromal cells (MSC), which are derived from adult human donor bone marrow then isolated and grown in culture before the StemSmart manufacturing process is applied to improve the cells’ clinical efficacy.

NeuroScientific reviewed historical studies, findings and publications prior to finalising the acquisition in an effort to determine whether other indications could benefit from StemSmart.

Phase 2 Crohn’s Trial

Early indications from a Phase 2 trial on 18 patients with refractory Crohn’s disease suggest StemSmart MSC can be potent, efficacious and safe, with the majority of patients experiencing clinical improvement and others in clinical remission.

NeuroScientific has since commenced work looking into fistulising Crohn’s disease under a special access scheme (SAS), which may provide early access to StemSmart for patients in need of alternative treatments with minimal side effects.

Fistulas are one of the most severe and debilitating complications associated with the disease and can be challenging to treat and heal with standard therapies.

If NeuroScientific’s SAS work is successful, the company could progress to a Phase 1/2 clinical trial.

StemSmart and GHVD

The company’s recent Phase 1 clinical trial of StemSmart MSC on adults and children with steroid-refractory GVHD found the majority of patients responded to the therapy with a complete or partial resolution of symptoms and improved survival rates.

The trial treated ten children (six classified as acute and four as chronic) on compassionate grounds and all survived to 12 months post-transplant, an improvement on anticipated mortality rates, with three of the chronic GVHD patients still alive more than six years after receiving the treatment.

“Although the numbers are small, the positive and life-saving clinical results for adults and children with severe and life-threatening steroid-refractory GVHD supports the use of StemSmart MSC therapy in this clinical indication, given the poor outlook of these patients,” the trial’s findings said.