Investigation of Small Mobile Stem Cells (SMS Cells) in Participants With Chronic Obstructive Pul… (NCT06986070) | Clinical Trial Compass
RecruitingPhase 1
Investigation of Small Mobile Stem Cells (SMS Cells) in Participants With Chronic Obstructive Pulmonary Disease (COPD).
Australia18 participantsStarted 2025-06-13
Plain-language summary
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.
Who can participate
Age range39 Years – 69 Years
SexALL
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Inclusion criteria
✓. Aged 39 to 69 years (inclusive).
✓. Female participants:
✓. Male participants:
✓. 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.
✓. Agrees to comply with study specific procedures and visits, including non-smoking during the treatment and follow-up periods of the study.
✓. Willing and able to provide written informed consent.
Exclusion criteria
✕. 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.
What they're measuring
1
Adverse events.
Timeframe: Day 1, 2, 3, 4, 5, 8, 9, 21, 28, Month 3 and Month 6.
2
Dose limiting toxicity.
Timeframe: Day 1, 2, 3, 4, 5, 8, 9, 21, 28, Month 3 and Month 6.
. 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.
✕. Any history of chronic liver disease, or abnormal liver function at screening, defined as:
✕. History of chronic renal insufficiency, defined as and eGFR \< 90 mL/min/1.73 m2. Participants without a history of chronic renal insufficiency, who at screening have an eGFR detected between 60-89 mL/min/1.73 m2, should have their eGFR repeated as per standard clinical procedure.
✕. Uncontrolled hypertension, or current hypertension controlled on more than two medications.
✕. History, within the last two years, of coronary artery disease, coronary artery bypass graft surgery, percutaneous transluminal coronary angioplasty, severe peripheral arterial disease, cerebrovascular disease (including history of transient ischemic attack or cerebrovascular accident), or any such history that, in the opinion of the investigator, will impact participation in the study.