NeuroScientific Biopharmaceuticals clears FDA hurdle for Crohn’s trial

Perth-based NeuroScientific Biopharmaceuticals has cleared a significant regulatory hurdle for its planned phase two clinical trial of StemSmart cell therapy. The therapy is being developed to treat patients with treatment-resistant Crohn’s disease.

During a pre-investigational new drug (Pre-IND) meeting, the U.S. Food and Drug Administration (FDA) responded positively to six of seven questions. The agency approved the proposed study design and the company’s existing human clinical evidence. Additionally, the FDA backed the StemSmart batch-testing plans and determined that no further non-clinical studies are required.

The StemSmart technology utilizes mesenchymal stem cells from adult donor bone marrow. The only remaining requirement is the implementation of a manufacturing protocol to ensure products are free from viral contamination, a step the company expects will have minimal impact on trial timelines.