NeuroScientific Chooses Q-Gen for its StemSmart Cell Therapy Platform

NeuroScientific Biopharmaceuticals has begun transferring its patented mesenchymal stromal cell manufacturing process to Q-Gen Cell Therapeutics, a division of the QIMR Berghofer Medical Research Institute, in Brisbane. 

StemSmart™ is an allogeneic MSC manufacturing platform initially developed by Royal Perth Hospital, then acquired by NeuroScientific Biopharmaceuticals. The platform is designed culture-expand allogeneic mesenchymal stromal cells (MSC) for patients with immune complications such as Crohn’s or steroid-refractory graft-versus-host disease. 

Early data from a Phase 2 trial involving 18 patients with refractory Crohn’s disease suggest that StemSmart™ MSCs are efficacious and safe. The majority of patients in the trial experienced clinical improvement, with some achieving clinical remission. The technology has also been used in early-phase clinical trials, additional studies, and on compassionate grounds for patients with severe and otherwise untreatable immune complications. Additionally, NeuroScientific is working on investigating StemSmart to treat fistulising Crohn’s disease under a Special Access Scheme (Australian version of expanded access), aiming to provide early access for patients who have not responded to standard therapies.  

They also just hired a new CMO, Dr. Cathy Cole, this week to help lead the new project. 

Q-Gen operates 13 cleanrooms dedicated to cell manufacturing and quality control. The company reports that the facility has over 25 years of experience and holds a Therapeutic Goods Administration (TGA – Australia’s regulatory authority) license for cell therapy manufacturing. According to the company, Q-Gen is among the largest and most experienced cell therapy manufacturing facilities in Australia, with a history of supporting national and international clinical trials involving cellular immunotherapies.

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