NeuroScientific Biopharmaceuticals gets US regulator's backing for Crohn's trial
The US Food and Drug Administration responded positively to six of seven questions about its development plan.
The US Food and Drug Administration (FDA) responded positively to six of seven questions. The FDA also backed the proposed trial design and accepted existing studies in people.
The only open item is a manufacturing plan to make sure the product is free of viral contamination. The company expects the required testing to have minimal impact on trial timelines.
The company aims to start the trial in Australia and the US by the end of 2026, subject to requirements. Crohn's disease is a lifelong condition with no cure that causes ongoing inflammation or swelling in the gut.
StemSmart is a treatment made from stem cells taken from adult donors' bone marrow. An earlier study of 18 patients with treatment-resistant Crohn's reported a 78 per cent response rate.
- Six of seven
- Questions answered positively
- 6 to 8 million worldwide
- Patients affected
- Around 30 per cent
- Share no longer responding
- Royal Perth Hospital
- Developed at
Why it mattersAround 30 per cent of Crohn's patients no longer respond to standard treatment. This is a step toward testing, not a treatment patients can use yet.
AustraliaAustralian sites are being set up to run the trial, so local patients may be able to join if it starts as planned.
✓ Claims checked against the source. checked 54 min ago
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