California-based SMSbiotech announced that the FDA has cleared its IND for a Phase 1b trial of its inhaled small mobile stem (SMS) cell therapy in patients with COPD and that the company intends to initiate the US study by the end of the year. SMSbiotech says that a Phase 1b trial of the nebulized stem cells is already underway in Australia and that a Phase 2a trial is planned for the first half of 2027.
According to the company, SMS cells “are a proprietary, blood-derived, allogeneic, off-the-shelf stem cell platform delivered directly to the lung via nebulized inhalation using an established nebulization device.” The announcement explains that what SMSbiotech calls “targeted multi-gene activity modulation (TMAM)” refers to “regenerative”multi-gene regenerative activity associated with alveolar tissue repair” resulting from the observed ability of SMS cells “to selectively bind to endogenous mesenchymal stem and progenitor cells in the lung.”
SMSbiotech President and Chief Scientific Officer Abdulkader Rahmo commented, “FDA authorization to proceed represents an important milestone for the science, the platform, and the team that built it. SMS cells appear to engage the lung’s own regenerative machinery through the TMAM cellular interaction, supported by a reproducible biomanufacturing process that is independent of donor availability. We now look forward to advancing this program with US patients.”
Company Chairman Joe Kiani said, “To our knowledge, SMSbiotech has achieved the first effective IND for an inhaled stem cell therapy in COPD, a significant milestone for both the company and the field of regenerative medicine. COPD remains without an approved disease-modifying treatment. We are committed to changing that.”
Read the SMSbiotech press release
