FDA grants SMSbiotech clearance for Phase 1b COPD stem cell study
1 report, 1 independent
Updated Oct 8
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What happened
SMSbiotech received a 'Study May Proceed' notification from the FDA in September 2026, allowing it to begin a US Phase 1b study of its investigational new drug application. The therapy involves proprietary, blood-derived allogeneic cell therapy administered through nebulized inhalation. The FDA stated that this clearance allows research to proceed but does not constitute treatment approval.
From pharmacytimes.com
Why it matters
The notification allows SMSbiotech to advance research into using Small Mobile Stem cells to influence lung repair machinery for Chronic Obstructive Pulmonary Disease. This regulatory milestone addresses the question of whether inhaled stem cells can produce lasting clinical benefit for COPD.
From pharmacytimes.com