SMSbiotech Receives FDA Clearance for Inhaled Stem Cell Therapy COPD Trial
The blood-derived, off-the-shelf cells are administered directly to the lungs through a standard nebulizer, with first U.S. patient dosing targeted for late 2026.
Key Points
- The FDA issued a “Study May Proceed” notification following its 30-day review of SMSbiotech’s investigational new drug application.
- An Australian Phase 1b COPD trial has completed its first cohort without therapy-related adverse events during the 28-day monitoring period.
- The blood-derived, allogeneic (donor derived) cells are administered through a standard nebulizer. Initial U.S. dosing is targeted for the fourth quarter of 2026.
SMSbiotech announced that the FDA has completed its review of the company’s investigational new drug application and issued a “Study May Proceed” notification. The notification allows SMSbiotech to initiate a U.S. Phase 1b clinical trial of inhaled Small Mobile Stem (SMS) Cells in patients with chronic obstructive pulmonary disease (COPD).
SMS Cells are a proprietary population of adult stem cells derived from human blood. The allogeneic (donor derived), off-the-shelf product is refrigerated and delivered directly to the lungs through nebulized inhalation using an established device.
Phase 1b Clinical Development
SMSbiotech is evaluating ascending doses of nebulized SMS Cells in an ongoing Phase 1b trial in Melbourne, Australia. Current trial and development updates include:
- The first of three cohorts completed the protocol-specified 28-day safety monitoring period with no therapy-related adverse events.
- Dose escalation to the second cohort is underway.
- First patient dosing in the U.S. Phase 1b trial is targeted for the fourth quarter of 2026.
- Subject to Phase 1b safety and tolerability results, SMSbiotech plans to begin a Phase 2a study in the first half of 2027.
COPD is characterized by progressive and irreversible lung tissue destruction. According to the World Health Organization, it is the third leading cause of death globally and causes more than 3.5 million deaths annually.
SMS Cell Platform
In preclinical studies, SMS Cells have been shown to selectively bind to endogenous mesenchymal stem and progenitor cells in the lungs. SMSbiotech reports that this interaction stimulates multi-gene regenerative activity associated with alveolar tissue repair. The company calls this interaction Targeted Multi-Gene Activity Modulation (TMAM).
Reported features and preclinical findings for the platform include:
- Nebulized administration: Direct-to-lung delivery through a standard nebulization device.
- Preclinical alveolar repair findings: Structural and functional lung recovery was observed in standard COPD animal models.
- Off-the-shelf supply: The allogeneic (donor derived) cells are produced through a scalable manufacturing process.
- Additional research areas: SMSbiotech reports proof-of-concept work in orthopedic and other human indications, as well as veterinary applications.
“FDA authorization to proceed represents an important milestone for the science, the platform, and the team that built it,” said Abdulkader Rahmo, Ph.D., Founder, President, and Chief Scientific Officer of SMSbiotech. “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 U.S. patients.”
About SMSbiotech
Founded in 2015, SMSbiotech is a clinical-stage regenerative medicine company developing adult SMS Cells derived from human blood. Its research includes chronic respiratory conditions, orthopedics, chronic wounds, vascular repair, and age-related diseases.
The company operates a GMP-compliant, ISO Class 7 manufacturing facility in San Diego and has received multiple patents covering SMS Cell technology and its uses. More information is available at SMSbiotech’s website.
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