StemSmart Crohn’s program receives favorable FDA pre-IND feedback; manufacturing testing remains
Published in Diseases!, Drugs development & discovery.
Publication date: October 13, 2026.
NeuroScientific Biopharmaceuticals reported favorable FDA feedback on the proposed design of a phase II StemSmart trial for treatment-resistant Crohn’s disease. Its October 13 announcement concerns a pre-IND consultation ahead of a planned US Investigational New Drug submission.
According to the company’s release, the FDA responded favorably to six of seven submitted questions, including the trial design, existing human evidence and proposed product release testing. The company says additional non-clinical studies were not requested. A remaining manufacturing issue concerns controls against viral contamination; NeuroScientific is implementing further testing.
StemSmart uses mesenchymal stromal/stem cells derived from adult donor bone marrow. The company is preparing studies in Australia and the United States, with a target start before the end of 2026.
Limits: favorable pre-IND advice does not constitute IND clearance or marketing approval. The start date remains conditional on regulatory, manufacturing and operational requirements. This update contains no new patient outcomes and does not establish efficacy or safety.
Source: Company media release distributed by Jane Morgan Management through Medianet, October 13, 2026.