Actively Recruiting
A Phase 1, First-in-Human Clinical Trial to Evaluate the Safety of Small Mobile Stem Cells Delivered Into the Lung as a Potential Organ Regeneration Therapy in COPD
Led by SMSbiotech · Updated on 2026-02-12
18
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of a new treatment called SORT-COPD, which involves inhaling small mobile stem cells (SMS cells) into the lungs of adults aged 39 to 69 with mild to moderate chronic obstructive pulmonary disease (COPD). This first-in-human Phase 1 study aims to find out if this treatment is safe at three different doses in people with COPD caused by cigarette smoking or biomass pollution exposure. Participants will be divided into three groups of six, each receiving increasing doses of SMS cells delivered through a medical nebulizer on days 1, 4, and 8. The nebulizer produces a mist containing the stem cells, which participants inhale for about 10 to 15 minutes. Between groups, there will be pauses to monitor for any side effects. The doses are 1.2 billion, 2.4 billion, and 4.8 billion cells per milliliter, with each group receiving the same dose across treatments. Each participant will be involved in the study for about 5 to 6 weeks, including screening, treatment, and follow-up visits. Researchers will perform various lung function tests, questionnaires, and safety labs at multiple timepoints up to 6 months after treatment. Participants will also be contacted by phone 3 to 6 months after treatment to check their health. The total participation may last up to 15 months, allowing detailed monitoring of safety and lung function changes.
CONDITIONS
Brief 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 must not be pregnant or breastfeeding and must use acceptable contraception if of childbearing potential
- Male participants must agree to abstain from donating semen and either remain abstinent or use contraception during and for 30 days after treatment
- Diagnosed with mild or moderate COPD-C or COPD-P according to 2023 GOLD criteria
- Previously treated for COPD-C or COPD-P
- Stable COPD with no exacerbations or hospitalizations in the 12 weeks before screening and no changes in COPD medication in the 28 days before screening
- Agree to comply with study procedures including non-smoking during the study
- Willing and able to provide written informed consent
You will not qualify if you...
- Diagnosis of COPD-G, COPD-D, COPD-I, COPD-A, COPD-U, asthma, congestive heart failure, bronchiectasis, tuberculosis, obliterative bronchiolitis, or diffuse panbronchiolitis
- History of respiratory failure not caused by COPD or relevant lung diseases detected by CT scan
- COVID-associated pneumonia with hypoxemic respiratory failure in the 12 weeks before screening
- Use of systemic corticosteroids within 21 days before screening; inhaled corticosteroids allowed with scheduling restrictions
- Chronic liver disease or abnormal liver function beyond specified limits
- Chronic renal insufficiency (eGFR < 90 mL/min/1.73 m2) or abnormal renal function on screening
- Uncontrolled hypertension or hypertension controlled with more than two medications
- Recent history of serious cardiovascular or cerebrovascular disease within 2 years
- Diabetes with HbA1c > 7.5% at screening
- Active malignancy in last 3 years except certain skin cancers
- History of HIV, immunosuppression, hepatitis B or C, or recent immunosuppressive medication use
- Active infection requiring antibiotics within 12 weeks before screening
- Body mass index over 60 kg/m2
- Active smoking or vaping within 28 days before screening
- History of substance abuse with less than 1 year of sobriety
- Pregnant or breastfeeding
- Severe medication allergies including bovine products
- Other medical or psychiatric conditions that may affect study tolerance or completion
- Participation in another clinical trial within 6 weeks or experimental therapy within 12 months
- Unable or unwilling to comply with study procedures or schedules
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Multiple visits during screening period
Duration - 8 days
Participants receive inhalation treatments of Small Mobile Stem Cells via a medical nebulizer on Days 1, 4, and 8 during in-clinic visits. Treatment dose increases by cohort with pauses between groups to monitor safety.
3 in-person visits for treatment
Duration - Approximately 4 weeks
Participants are monitored for safety and health outcomes for about 4 weeks after the first treatment through clinical visits and assessments.
Multiple follow-up visits up to Day 28
Duration - 3 to 6 months after treatment
Participants are contacted by telephone 3 to 6 months after completing treatment to answer questions about their health status.
1 telephone contact
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
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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