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Chronic Obstructive Lung DiseasePhase 1SORT-COPDNCT06986070

Investigation of Small Mobile Stem Cells (SMS Cells) in Participants With Chronic Obstructive Pulmonary Disease (COPD).

A Phase 1 study testing Stem cells in people with Chronic Obstructive Lung Disease, run by SMSbiotech at 1 site in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 39 to 69 years
Conditions the study is for
Chronic Obstructive Lung Disease
What is being tested?
Stem cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteAustralia
Study dates
13 Jun 2025to Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 39 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 of childbearing potential (WOCBP) and using an acceptable contraceptive method from screening until 30 days after the last dose of study intervention.
  • A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at Screening and on Day 1, prior to administration of study intervention.
  • If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
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  • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • 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 donating fresh unwashed semen. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR must agree to use contraception/barrier (male condom).
  • 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 impairment will be determined with post-bronchodilator FEV1 spirometry.
  • 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.

Who cannot join

  • 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.
  • 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 bilirubin more than two times the ULN Participants with documented Gilbert's syndrome are permitted to enter the study.
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  • 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.
  • 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 squamous cell carcinoma of the skin are eligible.
  • 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 administered.
  • 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, oral nicotine products or nicotine chewing gum is permitted, noting that cotinine results will be positive. Positive results will be documented by the investigator as "attributed to permitted nicotine products".
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Australia1 site, 1 recruiting

  • Doherty Clinical Trials Limited

    Melbourne, Victoria, 3002

    Grace Edwards, +61399704200, gedwards@dohertyclinicaltrials.com

    James Molton

    Recruiting

Other trials in Australia

About this study

Official title: A Phase 1, First-in-Human, Clinical Trial to Evaluate the Safety of Small Mobile Stem Cells (SMS) Delivered Into the Lung as a Potential Organ Regeneration Therapy in Chronic Obstructive Pulmonary Disease (SORT-COPD Study

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.

Read the detailed description

The 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.

18 participants are expected to be enrolled into this study. Participants will be divided into three groups of six volunteers, with the first group receiving the lowest dose of the study treatment, the second group receiving a higher dose, and the third group receiving the highest dose. Between each of the three groups, there will be a pause to permit detection of any short-term adverse effects of the treatment at a specific dose.

Participants will be treated with the study drug, SORT COPD (Small Mobile Stem Cells), delivered via a medical nebuliser on the 1st, 4th, and the 8th days of the study in-clinic. The nebuliser treatment involves inhaling mist from a mouthpiece attached to a standard medical nebuliser machine and takes about 10 to 15 minutes to complete.

The volume to be nebulised is 3 millilitres (less than one teaspoon). Participants in the cohort 1 (low dose) will receive 1.2 billion cells/ml. Participants in the cohort 2 (medium dose) will receive 2.4 billion cells/ml. Participants in the cohort 3 (high dose) will receive 4.8 billion cells/ml.

The study treatment (SMS) cells will be given in three different concentrations with the lowest dose given to the 1st group of 6 participants, with the dose doubled for each group. The members of each group will receive the same dose at each treatment visit.

Participants will actively be in the study for up to 5 or 6 weeks, including the initial screening and testing period before the treatment is applied, during treatment, and about 4 weeks after the first treatment. Also, about 3 to 6 months after the study, participants will be contacted via telephone to answer some questions about their state of health, which will be the end of the study.

Individual participant duration will be up to a maximum of 15 months.

Being tested
Stem cells
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stem cellsBiological

    Also called Small Molecule Stem (SMS) Cells

    The 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.

Study groups in NCT06986070
Study groupRoleWhat they receive
Participants in the cohort 1 (low dose) will receive 1.2 billion cells/ml.ExperimentalDose escalating Cohort 1.
Receives: Biological: Stem cells
Participants in the cohort 2 (medium dose) will receive 2.4 billion cells/ml.ExperimentalDose escalating Cohort 2.
Receives: Biological: Stem cells
Participants in the cohort 3 (high dose) will receive 4.8 billion cells/mExperimentalDose Escalating Cohort 3.
Receives: Biological: Stem cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events.

    Treatment emergent adverse events and serious adverse events.

    Measured: Day 1, 2, 3, 4, 5, 8, 9, 21, 28, Month 3 and Month 6.

  2. 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.

    Measured: Day 1, 2, 3, 4, 5, 8, 9, 21, 28, Month 3 and Month 6.

  3. 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.

    Measured: Screening, Day 2, 3, 5, 9, 21 and 28.

Secondary outcomes (13)

  1. 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).

    Measured: Screening, Day 1, 2, 3, 4, 5, 8, 9, 21 and 28.

  2. Spirometry

    To be performed according to the American Thoracic Society/European Respiratory Society Standards. Forced Vital Capacity (FVC) measured in liters (L).

    Measured: Screening, Day 1, 2, 3, 4, 5, 8, 9, 21 and 28.

  3. Oscillometry

    Resistance measured in cm H2O s/L .

    Measured: Screening, Day 1 and 28.

  4. Oscillometry

    Resistance change measured in cm H2O s/L..

    Measured: Screening, Day 1 and 28.

  5. Oscillometry

    Reactance of respiratory system measured in cm H2O s/L.

    Measured: Screening, Day 1 and 28.

  6. Plethysmograhy

    Functional Residual Capacity (FRC) measured in liters (L).

    Measured: Screening and Day 28.

  7. Plethysmograhy

    Total Lung Capacity (TLC) measured in liters (L).

    Measured: Screening and Day 28.

  8. Plethysmograhy

    Ratio of Residual Volume measured as a percentage (%).

    Measured: Screening and Day 28.

  9. Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)

    DLCO measured in milliliters per min per millimeter of Mercury (mL/min/mmHg).

    Measured: Screening and Day 28.

  10. Pulse oximetry

    Measuring oxygen saturation in the participants blood (SpO2)

    Measured: Screening, Day 1, 2, 3, 4, 5, 8, 9, 21 and 28.

  11. 6-minute walk-test

    Assessment of exercise tolerance , distance walked in 6-minutes measured in meters (m).

    Measured: Screening, Day 1, 5, 9, 21 and 28.

  12. Exhaled Nitirc Oxide Test

    The fractional exhaled nitric oxide (FENO) test measures the amount of nitric oxide that is exhaled from a breath. It is a marker of lung inflammation, and is useful for differentiating asthma from COPD and other conditions presenting with similar symptoms [26]. FENO values of < 25 parts per billion (ppb) are considered normal, 25-50 ppb as intermediate and > 50 ppb as high.

    Measured: Screening, Day 1, 2, 3, 4, 5, 8, 9, 21 and 28.

  13. St George Respiratory Questionnaire for COPD

    Measurement of quality of life validated for participants with COPD. Each subscale and the total score range from 0 (no impact) to 100 (worst possible impact).

    Measured: Screening, Day 1, Day 28, Month 3 and Month 6.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2025
  2. Study start13 Jun 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06986070
Sponsor's protocol ID
A005
Other IDs
ACTRN12624001140549
Acronym
SORT-COPD
Status last verified
Aug 2026
First submitted
13 Mar 2025
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: De-identified data will be published in a peer review scientific journal or presented at a scientific conference. There is no plan at this stage to make IPD available.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Stem cells in people with Chronic Obstructive Lung Disease, run by SMSbiotech at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events. (time frame: Day 1, 2, 3, 4, 5, 8, 9, 21, 28, Month 3 and Month 6.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06986070.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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