Phase 1/2Not yet recruitingAge-related condition
A Study to Investigate Small Mobile Stem Cells (SMS) in Moderate to Severe Chronic Obstructive Pulmonary Disease (SORT-COPD II)
A Phase 1b/2a, Clinical Trial to Evaluate the Safety, Tolerability, and Exploratory Activity of Small Mobile Stem Cells (SMS) Delivered Into the Lung as a Potential Organ Regeneration Therapy in Moderate to Severe Chronic Obstructive Pulmonary Disease (SORT-COPD Study II)
- Sponsor
- SMSbiotech (Industry)
- Enrolment
- 125 planned
- Conditions
- Chronic Obstructive Lung Disease
- Interventions
- Stem cells
- Ages
- adults, older adults
- Registry
- NCT07871890
Full record on ClinicalTrials.gov
From the registry
This study is a phase 1b/2a, open-label, non-randomized, observation of 125 adults, with moderate to severe chronic obstructive pulmonary disease, treated with SORT-COPD (SMS cells). The primary objective of this study is to evaluate the preliminary within-participant changes of SORT-COPD (SMS cells), in suspension, delivered to the lung as an aerosolized mist via a vibrating mesh nebulizer, on respiratory health status in participants with moderate to severe chronic obstructive pulmonary disease.
Primary outcomes
- Adverse events (AEs)
- Phase 1b: Dose-limiting toxicities (DLTs)
- Number of Participants With Clinically Significant Changes From Baseline in Hematology Laboratory Parameters
- Number of Participants With Clinically Significant Changes From Baseline in Serum Chemistry Laboratory Parameters
History
Study completion expected
Primary completion expected
Registered
Started