This study is a phase 1, first-in-human, open-label, non-randomized, dose escalation safety study of 18 participants, between 39 and 69 years of age, with mild to moderate chronic obstructive pulmonary disease, treated with SORT-COPD (SMS cells).
The primary objective of this study is to determine the safety of SORT-COPD (SMS cells) at three doses in people with chronic obstructive pulmonary disease.
Aged 39 to 69 years (inclusive).
Has a diagnosis of mild or moderate COPD-C (cigarette smoking COPD) or COPD-P (biomass and pollution exposure COPD) according to the 2023 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Criteria.
Has previously received treatment for COPD-C or COPD-P.
Has stable COPD disease state, defined as no exacerbations in the 12 weeks prior to screening, no hospitalizations in the 12 weeks prior to screening, and no changes in COPD medication in the 28 days prior to screening.
Previous or current diagnosis of COPD-G, COPD-D, COPD-I, COPD-A or COPD-U; asthma, congestive heart failure, bronchiectasis, tuberculosis, obliterative bronchiolitis or diffuse panbronchiolitis.
Previous or current history of respiratory failure other than due to COPD (e.g. restrictive lung disease, sarcoidosis, tuberculosis, idiopathic pulmonary fibrosis, bronchiectasis, CMV pneumonitis, cystic fibrosis, asbestosis, silicosis or farmer's lung disease), or detection of any of these conditions through screening CT scanning.
History of COVID associated pneumonia with hypoxemic respiratory failure in the 12 weeks prior to screening.
Current use, or use within 21 days of screening, of systemic corticosteroids. Participants on inhaled corticosteroids or combined inhaled therapies can be included, however must schedule inhaled therapies 12 hours prior to dosing IP and 12-hours post dosing IP.
Sequential
Stem cells
Biological/VaccineThe suspension of stem cells will be put in a medical nebulizer machine, commonly used to deliver medicines into the lungs through inhalation. This means that the participants will breathe in the mist containing the SMS cells, produced by the nebulizer machine. This is a Phase I First-in-Human study, which indicates that this treatment is being studied for the first time in humans.
Adverse events.
Treatment emergent adverse events and serious adverse events.
Dose limiting toxicity.
Any treatment emergent adverse event that ii treatment related and classified as severe or the event is classified as a serious adverse event.
Safety laboratory testing
All laboratory parameters will be summarized using descriptive statistics for each cohort and overall, for all time points assessed, including change from baseline for all post-dose assessments. Selected laboratory test results will be graded in accordance with the NCI CTCAE criteria.
Spirometry
To be performed according to the American Thoracic Society/European Respiratory Society Standards. Forced Expiratory Volume in 1 second (FEV1) measured in liters (L).
Spirometry
To be performed according to the American Thoracic Society/European Respiratory Society Standards. Forced Vital Capacity (FVC) measured in liters (L).
Oscillometry
Resistance measured in cm H2O s/L .
Oscillometry
Resistance change measured in cm H2O s/L..
