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

NCT06986070 | Recruiting Phase 1

• 2 other identifiers: A005ACTRN12624001140549
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Obstructive Lung Disease

Outcome Measures

Primary Outcomes (3)

• Adverse events.

  Treatment emergent adverse events and serious adverse events.

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

• 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.

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

• 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.

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

Secondary Outcomes (13)

• Spirometry

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

• Spirometry

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

• Oscillometry

  Screening, Day 1 and 28.

• Oscillometry

  Screening, Day 1 and 28.

• Oscillometry

  Screening, Day 1 and 28.

Study Arms (3)

Participants in the cohort 1 (low dose) will receive 1.2 billion cells/ml.

EXPERIMENTAL

Dose escalating Cohort 1.

Biological: Stem cells

Participants in the cohort 2 (medium dose) will receive 2.4 billion cells/ml.

EXPERIMENTAL

Dose escalating Cohort 2.

Biological: Stem cells

Participants in the cohort 3 (high dose) will receive 4.8 billion cells/m

EXPERIMENTAL

Dose Escalating Cohort 3.

Biological: Stem cells

Interventions

Stem cells BIOLOGICAL

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.

Also known as: Small Molecule Stem (SMS) Cells

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/m

Eligibility Criteria

• Age: 39 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• SMSbiotech: lead

Study Sites (2)

Veritus Research

Bayswater, Victoria, 3153, Australia

RECRUITING

Doherty Clinical Trials Limited

Melbourne, Victoria, 3002, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Spermine Synthase; Cell Count

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cell Physiological Phenomena

Study Officials

• Rebecca Wolf, Medical Doctor

  Veritus Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Wolf, Medical Doctor

CONTACT

+61 3 8736 1750; info@veritusresearch.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: May 22, 2025
• Study Start: June 13, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)