Actively Recruiting
Investigation of Small Mobile Stem Cells (SMS Cells) in Participants With Chronic Obstructive Pulmonary Disease (COPD).
Led by SMSbiotech · Updated on 2026-02-12
18
Participants Needed
2
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Investigation of Small Mobile Stem Cells (SMS Cells) in Participants With Chronic Obstructive Pulmonary Disease (COPD).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 39 to 69 years (inclusive).
- Female participants not pregnant or breastfeeding and either not of childbearing potential or using contraception from screening until 30 days after last dose.
- Female participants of childbearing potential must have negative pregnancy tests at screening and Day 1.
- Male participants must agree to abstain from donating fresh unwashed semen and either be abstinent or use contraception during treatment and for 30 days after last dose.
- Diagnosis of mild or moderate COPD caused by cigarette smoking or biomass/pollution exposure according to 2023 GOLD criteria.
- Previously treated for COPD-C or COPD-P.
- Stable COPD with no exacerbations or hospitalizations in 12 weeks prior to screening and no changes in COPD medication in 28 days prior to screening.
- Agree to comply with study procedures and visits, including not smoking during treatment and follow-up.
- Willing and able to provide written informed consent.
You will not qualify if you...
- 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.
- History or current respiratory failure other than COPD or detection of restrictive lung diseases or other specified lung conditions via screening CT.
- COVID-associated pneumonia with hypoxemic respiratory failure within 12 weeks prior to screening.
- Use of systemic corticosteroids currently or within 21 days before screening (inhaled corticosteroids allowed with timing restrictions).
- Chronic liver disease or abnormal liver function with ALT/AST >2.5x upper limit or bilirubin >2x upper limit (except Gilbert's syndrome).
- Chronic renal insufficiency with eGFR <90 mL/min/1.73 m2.
- Uncontrolled hypertension or hypertension controlled with more than two medications.
- History of serious cardiovascular or cerebrovascular disease within last two years.
- Diabetes with HbA1c >7.5% at screening.
- Active malignancy in last three years or suspicious nodules >5 mm on CT (except certain skin cancers).
- History of HIV, hepatitis B or C, immunosuppression, or use of immunosuppressive drugs near screening and treatment.
- Active infection requiring systemic antibiotics within 12 weeks prior to screening.
- Body mass index over 60 kg/m2.
- Active smoking or vaping tobacco, cannabis, or nicotine products within 28 days prior to screening as per urine test.
- History of substance abuse with less than one year sobriety.
- Pregnant or breastfeeding.
- Severe medication allergies including bovine products.
- Any medical or psychiatric condition that might prevent tolerating inhalation treatment or completing the study.
- Current or recent participation in other clinical trials or recent use of experimental therapies.
- Unable or unwilling to comply with study schedules or procedures.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Veritus Research
Bayswater, Victoria, Australia, 3153
Actively Recruiting
2
Doherty Clinical Trials Limited
Melbourne, Victoria, Australia, 3002
Not Yet Recruiting
Research Team
R
Rebecca Wolf, Medical Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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