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New treatment option for Chronic Obstructive Lung Disease
Official title Investigation of Small Mobile Stem Cells (SMS Cells) in Participants With Chronic Obstructive Pulmonary Disease (COPD).
ClinicalTrials.gov ID: NCT06986070
What this study is testing
What is Stem cells?
Stem cells is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for chronic obstructive lung disease.
Also referred to as Small Molecule Stem (SMS) Cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 39 to 69
You may be able to join if
- Aged 39 to 69 years (inclusive).
- Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions...
- Male participants: Male participants are eligible to participate if they agree to the following during the study intervention period and for at least...
- 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...
- Has previously received treatment for COPD-C or COPD-P.
You likely can't join if
- Previous or current diagnosis of COPD-G, COPD-D, COPD-I, COPD-A or COPD-U; asthma, congestive heart failure, bronchiectasis, tuberculosis...
- Previous or current history of respiratory failure other than due to COPD (e.g. restrictive lung disease, sarcoidosis, tuberculosis, idiopathic...
- 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...
- Any history of chronic liver disease, or abnormal liver function at screening, defined as: Alanine transaminase (ALT) and/or aspartate...
- History of chronic renal insufficiency, defined as and eGFR \< 90 mL/min/1.73 m2. Participants without a history of chronic renal insufficiency, who...
See the full eligibility criteria
- Aged 39 to 69 years (inclusive).
- Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of nonchildbearing potential (WONCBP) OR Is a woman...
- Male participants: Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 30 days after the last dose of study intervention: Refrain from...
- 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. Lung...
- 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.
- 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...
- 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...
- Any history of chronic liver disease, or abnormal liver function at screening, defined as: Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) more than 2.5 times the upper limit of normal (ULN) Total...
- 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...
- 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...
- Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c \> 7.5%) at screening.
- No active malignancy in the last three years, including any potential neoplasm detected via high-resolution CT scan (nodule \> 5 mm) detected as part of the screening process. People with a history of basal cell or...
- History of HIV or other immunosuppressed conditions, Hepatitis B or Hepatitis C, or use of immunosuppressive medications within 14 days prior to screening, and for 3 weeks after the last dose of study intervention is...
- Active infection requiring systemic antibiotic treatment within 12 weeks prior to screening.
- Body mass index (BMI) \> 60 kg/m2.
- Active smoking of tobacco, cannabis or vaping in the 28 days prior to screening as indicated by results of cotinine urine testing, performed at screening. Use of nicotine containing products such as nicotine patches...
- History of alcohol or other substance abuse, with sobriety less than one year, or that in the opinion of the investigator, will impact participation in the study.
- Pregnant or breastfeeding.
- Any severe medication allergy, including an allergy to bovine products.
- Any other medical condition, psychiatric condition or illness, that according to the Principal Investigator might render the subject unlikely to tolerate the inhalation of SORT-COPD (SMS cells), or to complete the study.
- Current participation in any other clinical trial or participation in the last six weeks or subject received an experimental therapy (drug or biologic) for any indication within 12 months prior to enrolment.
- Unable or unwilling to comply with study specific schedules or procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Bayswater, Victoria, Australia
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 39 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bayswater, Victoria, Australia; Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.