Chronic Obstructive Lung DiseasePhase 1/2SORT-COPD IINCT07871890
A Study to Investigate Small Mobile Stem Cells (SMS) in Moderate to Severe Chronic Obstructive Pulmonary Disease
A Phase 1/2 study testing Stem cells in people with Chronic Obstructive Lung Disease, run by SMSbiotech at 1 site in United States.
Trial summary
This study is a phase 1b/2a, open-label, non-randomized, observation of 125 adults, with moderate to severe chronic obstructive pulmonary disease, treated with SORT-COPD (SMS cells). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Lung Disease
- What is being tested?
- Stem cells
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to Dec 2027
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants must meet all of the following inclusion criteria:
- Adult >18 yrs old (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.
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- 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.
- 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 moderate to severe 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 [1, 2].
- 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 4 weeks prior to screening, no hospitalizations in the 4 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
- Participants must not meet any of the exclusion criteria.
- 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 or inhaled corticosteroids. Participants on inhaled corticosteroids or combined inhaled therapies can be included; however, they must schedule inhaled therapies 12 hours prior to dosing IP and 12 hours post-dosing IP.
- History of chronic renal insufficiency, defined as an eGFR < 90 mL/min/1.73 m² [3] and/or defined as abnormalities of kidney structure or function, present for >3 months. Participants without a history of chronic renal insufficiency, who at screening have an eGFR detected between 60-89 mL/min/1.73 m², may be enrolled and receive IP per the investigator's discretion.
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- Uncontrolled hypertension, or current hypertension controlled on more than two medications.
- History 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).
- Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c > 7.5%) at screening.
- History or active malignancy, 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.
- Received an experimental therapy (drug or biologic) for any indication within 12 months prior to enrollment.
- Unable or unwilling to comply with study specific schedules or procedures.
- Positive test for COVID-19, Influenza A, Influenza B or RSV on day 1.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Miami
Miami, Florida, 33136
Research Project Manager, MPH, 305-243-6388
Trishul Siddharthan, MD
About this study
Official title: A Phase 1b/2a, Clinical Trial to Evaluate the Safety, Tolerability, and Exploratory Activity of Small Mobile Stem Cells (SMS) Delivered Into the Lung as a Potential Organ Regeneration Therapy in Moderate to Severe Chronic Obstructive Pulmonary Disease (SORT-COPD Study II)
This study is a phase 1b/2a, open-label, non-randomized, observation of 125 adults, with moderate to severe chronic obstructive pulmonary disease, treated with SORT-COPD (SMS cells).
The primary objective of this study is to evaluate the preliminary within-participant changes of SORT-COPD (SMS cells), in suspension, delivered to the lung as an aerosolized mist via a vibrating mesh nebulizer, on respiratory health status in participants with moderate to severe chronic obstructive pulmonary disease.
Read the detailed description
SORT-COPD II is a Phase 1b/2a, open-label, non-randomized, single-arm clinical study evaluating an investigational biologic therapy called SORT-COPD in adults with moderate to severe chronic obstructive pulmonary disease (COPD). SORT-COPD consists of Small Mobile Stem (SMS) cells suspended in Hank's Balanced Salt Solution and delivered directly to the lungs as an aerosolized mist using a vibrating mesh nebulizer.
SMS cells are small adult stem cells derived from human blood. Laboratory and animal studies suggest that these cells may bind to cells involved in lung repair and influence inflammatory, vascular, extracellular matrix, and tissue-repair processes. SORT-COPD is being investigated as a potential regenerative and disease-modifying therapy for COPD. However, its safety and potential clinical effects in people with COPD have not been fully established, and participation may not provide an individual medical benefit.
Up to 125 participants will be enrolled. The first 5 participants will form the Phase 1b portion of the study. These participants will receive the protocol-specified treatment regimen and will be followed through the Day 28 safety assessment. An independent Data Safety Monitoring Committee will then review the available safety and tolerability information before enrollment proceeds into Phase 2a.
If the Data Safety Monitoring Committee recommends continuation, an additional 120 participants will be enrolled in the Phase 2a portion. The Phase 2a portion is intended to further characterize safety and to estimate changes from baseline following treatment. The results will be used to inform the design of subsequent controlled clinical trials. The Data Safety Monitoring Committee will continue to review cumulative safety information during the study and may recommend that enrollment or treatment continue as planned, be temporarily paused, be modified, or be stopped.
All participants will receive the same treatment regimen. On each treatment day, participants will receive 2.4 billion SMS cells by oral inhalation through an Aerogen Solo vibrating mesh nebulizer used with an Aerogen Ultra device. Treatment will be administered at the study site on Days 1, 3, and 6, for a total planned dose of 7.2 billion SMS cells per participant.
For each treatment, three vials containing 0.8 billion SMS cells in 1 mL will be used. Each vial will be diluted with an additional 1 mL of Hank's Balanced Salt Solution before nebulization. The three diluted portions provide 6 mL of investigational cell suspension. After the cell suspension has been administered, an additional 3 mL of Hank's Balanced Salt Solution without SMS cells will be nebulized as a washout. The total nebulized volume on each treatment day will therefore be 9 mL. Administration is expected to take approximately 30 minutes.
Participants will undergo screening for up to 30 days before the first treatment. Study visits and assessments will include medical examinations, safety laboratory testing, electrocardiograms, monitoring for adverse events, pulmonary function testing, exercise assessments, respiratory questionnaires, and lung imaging. Participants will be monitored at the study site during and after each treatment. Follow-up will continue through approximately 12 months after treatment, and each participant is expected to remain in the study for up to approximately 13 months.
- Conditions
- Chronic Obstructive Lung Disease
- 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 Small Mobile Stem (SMS) cells will be placed into a medical nebulizer machine, commonly used to deliver medicines into the lungs through inhalation. Participants with moderate to severe chronic obstructive pulmonary disease (COPD) will breathe in the mist containing the SMS cells through a mouthpiece. The treatment will be given at the study site on Days 1, 3, and 6. Each treatment will contain 2.4 billion SMS cells and will take approximately 30 minutes to complete. This is a Phase 1b/2a study designed to evaluate the safety, tolerability, and potential effects of SMS cells in people with moderate to severe COPD.
| Study group | Role | What they receive |
|---|---|---|
| Safety Cohort (Phase 1b) | Experimental | Participants receive 2.4 billion SMS cells by oral inhalation via vibrating mesh nebulizer on Days 1, 3, and 6 (total: 7.2 billion cells). Safety and tolerability are reviewed by an independent DSMC through Day 28 prior to Phase 2a enrollment. Receives: Biological: Stem cells |
| Expansion Cohort (Phase 2a) | Experimental | Participants receive the same treatment regimen as Cohort 1: 2.4 billion SMS cells by oral inhalation via vibrating mesh nebulizer on Days 1, 3, and 6 (total: 7.2 billion cells), following DSMC review of Phase 1b safety data. Receives: Biological: Stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) graded using CTCAE Version 6.0, and incidence of treatment-related TEAEs, Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Measured: Baseline through 12 months
Phase 1b: Dose-limiting toxicities (DLTs)
Incidence of DLTs and and participant stopping-rule events during Phase 1b safety review period prior to Phase 2a expansion
Measured: Baseline through Day 28
Number of Participants With Clinically Significant Changes From Baseline in Hematology Laboratory Parameters
Number of participants with at least one clinically significant change from baseline in hematology laboratory parameters, as determined by the investigator based on the laboratory reference range, magnitude of change from baseline, and clinical relevance. Hematology assessments include protocol-specified parameters such as hemoglobin, hematocrit, red blood cell count, white blood cell count with differential, and platelet count. Participants with one or more clinically significant hematology abnormalities will be counted once for this outcome measure.
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Changes From Baseline in Serum Chemistry Laboratory Parameters
Number of participants with at least one clinically significant change from baseline in serum chemistry laboratory parameters, as determined by the investigator based on the laboratory reference range, magnitude of change from baseline, and clinical relevance. Serum chemistry assessments include protocol-specified measures of renal function, hepatic function, electrolytes, glucose, and other chemistry parameters. Participants with one or more clinically significant serum chemistry abnormalities will be counted once for this outcome measure.
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant ECG Abnormalities
Number of participants with at least one clinically significant electrocardiogram abnormality, as determined by the investigator. ECG assessment will include heart rate, PR interval, QRS duration, QT interval, and corrected QT interval (QTc). Participants with one or more clinically significant ECG abnormalities will be counted once for this outcome measure.
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Changes From Baseline in Systolic Blood Pressure
Number of participants with a clinically significant change from baseline in systolic blood pressure, measured in millimeters of mercury (mmHg), as determined by the investigator based on the magnitude of change and clinical relevance.
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Changes From Baseline in Diastolic Blood Pressure
Number of participants with a clinically significant change from baseline in diastolic blood pressure, measured in millimeters of mercury (mmHg), as determined by the investigator based on the magnitude of change and clinical relevance.
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Changes From Baseline in Heart Rate
Number of participants with a clinically significant change from baseline in heart rate, measured in beats per minute, as determined by the investigator based on the magnitude of change and clinical relevance.
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Changes From Baseline in Respiratory Rate
Number of participants with a clinically significant change from baseline in respiratory rate, measured in breaths per minute, as determined by the investigator based on the magnitude of change and clinical relevance.
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Changes From Baseline in Peripheral Oxygen Saturation
Number of participants with a clinically significant change from baseline in peripheral oxygen saturation (SpO2), measured as percent oxygen saturation by pulse oximetry, as determined by the investigator based on the magnitude of change and clinical relevance.
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Abnormal Physical Examination Findings
Number of participants with at least one new or worsened clinically significant abnormal finding identified during physical examination after study treatment, as determined by the investigator. Participants with multiple clinically significant physical examination findings will be counted once for this outcome measure.
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Changes From Baseline in Pre-Dose FEV1
Number of participants with a clinically significant change from baseline in pre-dose forced expiratory volume in 1 second (FEV1), measured in liters by spirometry, as determined by the investigator based on the magnitude of change and clinical relevance.
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Changes From Pre-Dose to Post-Dose FEV1
Number of participants with a clinically significant change in forced expiratory volume in 1 second (FEV1) from the pre-dose measurement to the protocol-specified post-dose measurement, measured in liters by spirometry, as determined by the investigator based on the magnitude of change and clinical relevance.
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Changes From Baseline in Pre-Dose FVC
Number of participants with a clinically significant change from baseline in pre-dose forced vital capacity (FVC), measured in liters by spirometry, as determined by the investigator based on the magnitude of change and clinical relevance.
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Changes From Pre-Dose to Post-Dose FVC
Number of participants with a clinically significant change in forced vital capacity (FVC) from the pre-dose measurement to the protocol-specified post-dose measurement, measured in liters by spirometry, as determined by the investigator based on the magnitude of change and clinical relevance.
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Treatment-Emergent Hypersensitivity Reactions
Number of participants experiencing at least one treatment-emergent hypersensitivity reaction during or following administration of study treatment. Hypersensitivity reactions will be identified by the investigator based on protocol-defined clinical signs and symptoms, including allergic or systemic hypersensitivity manifestations. Participants experiencing more than one hypersensitivity reaction will be counted once for this outcome measure.
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Treatment-Emergent Inhalation-Related Reactions
Number of participants experiencing at least one treatment-emergent respiratory or inhalation-related reaction during or following nebulized study treatment. Reactions may include protocol-defined respiratory signs or symptoms such as cough, wheezing, chest tightness, dyspnea, bronchospasm, or clinically significant oxygen desaturation. Participants experiencing more than one inhalation-related reaction will be counted once for this outcome measure.
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Secondary outcomes (17)
Spirometry
Within-participant absolute change from baseline in post-bronchodilator Forced Expiratory Volume in One Second (FEV1), measured in liters (L), performed according to ATS/ERS standards
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Spirometry
Within-participant change from baseline in post-bronchodilator FEV1 z-score, calculated using GLI Global reference equations
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Spirometry
Within-participant change from baseline in Percent Predicted FEV1 (ppFEV1), measured in percentage points and calculated using GLI Global reference equations
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Spirometry
Within-participant change from baseline in Forced Vital Capacity (FVC), measured in liters (L), performed according to ATS/ERS standards
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Spirometry
Within-participant change from baseline in FEV1/FVC Ratio, measured as a percentage (%)
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Oscillometry
Within-participant change from baseline in respiratory system Resistance (Rrs) over differing frequencies, measured in cmH2O/L/s, performed according to ERS technical standards
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Oscillometry
Within-participant change from baseline in respiratory system Reactance (Xrs) over differing frequencies, measured in cmH2O/L/s, performed according to ERS technical standards
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Oscillometry
Within-participant change from baseline in Reactance Area (AX), measured in cmH20/L
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Plethysmography
Within-participant change from baseline in Functional Residual Capacity (FRC), measured in liters (L), performed according to ATS/ERS standards
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Plethysmography
Within-participant change from baseline in Total Lung Capacity (TLC), measured in liters (L), performed according to ATS/ERS standards
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Plethysmography
Within-participant change from baseline in Ratio of Residual Volume (RV/TLC), measured as a percentage (%)
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)
Within-participant change from baseline in DLCO
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Six-Minute Walk Test (6MWT)
Within-participant change from baseline in 6MWT total distance, heart rate, oxygen saturation, fatigue score, and dyspnea score
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
Fractional Exhaled Nitric Oxide (FeNO)
Within-participant change from baseline in FeNO
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
St. George's Respiratory Questionnaire (SGRQ)
Within-participant change from baseline in St. George's Respiratory Questionnaire total score. Total score ranges from 0 to 100, with higher scores indicating worse respiratory health status and greater impairment in health-related quality of life. Lower scores indicate better outcomes.
Measured: Baseline, Day 28, 3 months, 6 months, 12 months
COPD exacerbations
Number of exacerbations, time to first exacerbation, exacerbations requiring systemic corticosteroids or antibiotics, emergency department visits, and hospitalizations
Measured: Baseline through 12 months
Computed Tomography (CT)
CT lung densitometry
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SMSbiotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Trishul Siddharthan, Medical Doctor, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871890
- Sponsor's protocol ID
- A008
- Acronym
- SORT-COPD II
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2a, Clinical Trial to Evaluate the Safety, Tolerability, and Exploratory Activity of Small Mobile Stem Cells (SMS) Delivered Into the Lung as a Potential Organ Regeneration Therapy in Moderate to Severe Chronic Obstructive Pulmonary Disease (SORT-COPD Study II)
- ClinicalTrials.gov ID
- NCT07871890
- Acronym / sponsor ID
- SORT-COPD II / A008
- Conditions
- Chronic Obstructive Lung Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- SMSbiotechIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a phase 1b/2a, open-label, non-randomized, observation of 125 adults, with moderate to severe chronic obstructive pulmonary disease, treated with SORT-COPD (SMS cells).
The primary objective of this study is to evaluate the preliminary within-participant changes of SORT-COPD (SMS cells), in suspension, delivered to the lung as an aerosolized mist via a vibrating mesh nebulizer, on respiratory health status in participants with moderate to severe chronic obstructive pulmonary disease.
Detailed description
SORT-COPD II is a Phase 1b/2a, open-label, non-randomized, single-arm clinical study evaluating an investigational biologic therapy called SORT-COPD in adults with moderate to severe chronic obstructive pulmonary disease (COPD). SORT-COPD consists of Small Mobile Stem (SMS) cells suspended in Hank's Balanced Salt Solution and delivered directly to the lungs as an aerosolized mist using a vibrating mesh nebulizer.
SMS cells are small adult stem cells derived from human blood. Laboratory and animal studies suggest that these cells may bind to cells involved in lung repair and influence inflammatory, vascular, extracellular matrix, and tissue-repair processes. SORT-COPD is being investigated as a potential regenerative and disease-modifying therapy for COPD. However, its safety and potential clinical effects in people with COPD have not been fully established, and participation may not provide an individual medical benefit.
Up to 125 participants will be enrolled. The first 5 participants will form the Phase 1b portion of the study. These participants will receive the protocol-specified treatment regimen and will be followed through the Day 28 safety assessment. An independent Data Safety Monitoring Committee will then review the available safety and tolerability information before enrollment proceeds into Phase 2a.
If the Data Safety Monitoring Committee recommends continuation, an additional 120 participants will be enrolled in the Phase 2a portion. The Phase 2a portion is intended to further characterize safety and to estimate changes from baseline following treatment. The results will be used to inform the design of subsequent controlled clinical trials. The Data Safety Monitoring Committee will continue to review cumulative safety information during the study and may recommend that enrollment or treatment continue as planned, be temporarily paused, be modified, or be stopped.
All participants will receive the same treatment regimen. On each treatment day, participants will receive 2.4 billion SMS cells by oral inhalation through an Aerogen Solo vibrating mesh nebulizer used with an Aerogen Ultra device. Treatment will be administered at the study site on Days 1, 3, and 6, for a total planned dose of 7.2 billion SMS cells per participant.
For each treatment, three vials containing 0.8 billion SMS cells in 1 mL will be used. Each vial will be diluted with an additional 1 mL of Hank's Balanced Salt Solution before nebulization. The three diluted portions provide 6 mL of investigational cell suspension. After the cell suspension has been administered, an additional 3 mL of Hank's Balanced Salt Solution without SMS cells will be nebulized as a washout. The total nebulized volume on each treatment day will therefore be 9 mL. Administration is expected to take approximately 30 minutes.
Participants will undergo screening for up to 30 days before the first treatment. Study visits and assessments will include medical examinations, safety laboratory testing, electrocardiograms, monitoring for adverse events, pulmonary function testing, exercise assessments, respiratory questionnaires, and lung imaging. Participants will be monitored at the study site during and after each treatment. Follow-up will continue through approximately 12 months after treatment, and each participant is expected to remain in the study for up to approximately 13 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safety Cohort (Phase 1b) | Experimental | Biological: Stem cellsParticipants receive 2.4 billion SMS cells by oral inhalation via vibrating mesh nebulizer on Days 1, 3, and 6 (total: 7.2 billion cells). Safety and tolerability are reviewed by an independent DSMC through Day 28 prior to Phase 2a enrollment. |
| Expansion Cohort (Phase 2a) | Experimental | Biological: Stem cellsParticipants receive the same treatment regimen as Cohort 1: 2.4 billion SMS cells by oral inhalation via vibrating mesh nebulizer on Days 1, 3, and 6 (total: 7.2 billion cells), following DSMC review of Phase 1b safety data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Eligible participants must meet all of the following inclusion criteria:
- Adult >18 yrs old (inclusive).
- Female participants:
- 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.
- Has a diagnosis of moderate to severe 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 [1, 2].
Key exclusion criteria (22 listed)
- Participants must not meet any of the exclusion criteria.
- 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 or inhaled corticosteroids. Participants on inhaled corticosteroids or combined inhaled therapies can be included; however, they must schedule inhaled therapies 12 hours prior to dosing IP and 12 hours post-dosing IP.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stem cellsAlso: Small Molecule Stem (SMS) CellsThe suspension of Small Mobile Stem (SMS) cells will be placed into a medical nebulizer machine, commonly used to deliver medicines into the lungs through inhalation. Participants with moderate to severe chronic obstructive pulmonary disease (COPD) will breathe in the mist containing the SMS cells through a mouthpiece. The treatment will be given at the study site on Days 1, 3, and 6. Each treatment will contain 2.4 billion SMS cells and will take approximately 30 minutes to complete. This is a Phase 1b/2a study designed to evaluate the safety, tolerability, and potential effects of SMS cells in people with moderate to severe COPD. | Biological | Expansion Cohort (Phase 2a), Safety Cohort (Phase 1b) |
Primary outcome
Adverse events (AEs)
Time frame: Baseline through 12 months
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) graded using CTCAE Version 6.0, and incidence of treatment-related TEAEs, Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Phase 1b: Dose-limiting toxicities (DLTs)
Time frame: Baseline through Day 28
Incidence of DLTs and and participant stopping-rule events during Phase 1b safety review period prior to Phase 2a expansion
Number of Participants With Clinically Significant Changes From Baseline in Hematology Laboratory Parameters
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Number of participants with at least one clinically significant change from baseline in hematology laboratory parameters, as determined by the investigator based on the laboratory reference range, magnitude of change from baseline, and clinical relevance. Hematology assessments include protocol-specified parameters such as hemoglobin, hematocrit, red blood cell count, white blood cell count with differential, and platelet count. Participants with one or more clinically significant hematology abnormalities will be counted once for this outcome measure.
Number of Participants With Clinically Significant Changes From Baseline in Serum Chemistry Laboratory Parameters
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Number of participants with at least one clinically significant change from baseline in serum chemistry laboratory parameters, as determined by the investigator based on the laboratory reference range, magnitude of change from baseline, and clinical relevance. Serum chemistry assessments include protocol-specified measures of renal function, hepatic function, electrolytes, glucose, and other chemistry parameters. Participants with one or more clinically significant serum chemistry abnormalities will be counted once for this outcome measure.
Number of Participants With Clinically Significant ECG Abnormalities
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Number of participants with at least one clinically significant electrocardiogram abnormality, as determined by the investigator. ECG assessment will include heart rate, PR interval, QRS duration, QT interval, and corrected QT interval (QTc). Participants with one or more clinically significant ECG abnormalities will be counted once for this outcome measure.
Number of Participants With Clinically Significant Changes From Baseline in Systolic Blood Pressure
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Number of participants with a clinically significant change from baseline in systolic blood pressure, measured in millimeters of mercury (mmHg), as determined by the investigator based on the magnitude of change and clinical relevance.
Number of Participants With Clinically Significant Changes From Baseline in Diastolic Blood Pressure
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Number of participants with a clinically significant change from baseline in diastolic blood pressure, measured in millimeters of mercury (mmHg), as determined by the investigator based on the magnitude of change and clinical relevance.
Number of Participants With Clinically Significant Changes From Baseline in Heart Rate
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Number of participants with a clinically significant change from baseline in heart rate, measured in beats per minute, as determined by the investigator based on the magnitude of change and clinical relevance.
Number of Participants With Clinically Significant Changes From Baseline in Respiratory Rate
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Number of participants with a clinically significant change from baseline in respiratory rate, measured in breaths per minute, as determined by the investigator based on the magnitude of change and clinical relevance.
Number of Participants With Clinically Significant Changes From Baseline in Peripheral Oxygen Saturation
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Number of participants with a clinically significant change from baseline in peripheral oxygen saturation (SpO2), measured as percent oxygen saturation by pulse oximetry, as determined by the investigator based on the magnitude of change and clinical relevance.
Number of Participants With Clinically Significant Abnormal Physical Examination Findings
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Number of participants with at least one new or worsened clinically significant abnormal finding identified during physical examination after study treatment, as determined by the investigator. Participants with multiple clinically significant physical examination findings will be counted once for this outcome measure.
Number of Participants With Clinically Significant Changes From Baseline in Pre-Dose FEV1
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Number of participants with a clinically significant change from baseline in pre-dose forced expiratory volume in 1 second (FEV1), measured in liters by spirometry, as determined by the investigator based on the magnitude of change and clinical relevance.
Number of Participants With Clinically Significant Changes From Pre-Dose to Post-Dose FEV1
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Number of participants with a clinically significant change in forced expiratory volume in 1 second (FEV1) from the pre-dose measurement to the protocol-specified post-dose measurement, measured in liters by spirometry, as determined by the investigator based on the magnitude of change and clinical relevance.
Number of Participants With Clinically Significant Changes From Baseline in Pre-Dose FVC
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Number of participants with a clinically significant change from baseline in pre-dose forced vital capacity (FVC), measured in liters by spirometry, as determined by the investigator based on the magnitude of change and clinical relevance.
Number of Participants With Clinically Significant Changes From Pre-Dose to Post-Dose FVC
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Number of participants with a clinically significant change in forced vital capacity (FVC) from the pre-dose measurement to the protocol-specified post-dose measurement, measured in liters by spirometry, as determined by the investigator based on the magnitude of change and clinical relevance.
Number of Participants With Treatment-Emergent Hypersensitivity Reactions
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Number of participants experiencing at least one treatment-emergent hypersensitivity reaction during or following administration of study treatment. Hypersensitivity reactions will be identified by the investigator based on protocol-defined clinical signs and symptoms, including allergic or systemic hypersensitivity manifestations. Participants experiencing more than one hypersensitivity reaction will be counted once for this outcome measure.
Number of Participants With Treatment-Emergent Inhalation-Related Reactions
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Number of participants experiencing at least one treatment-emergent respiratory or inhalation-related reaction during or following nebulized study treatment. Reactions may include protocol-defined respiratory signs or symptoms such as cough, wheezing, chest tightness, dyspnea, bronchospasm, or clinically significant oxygen desaturation. Participants experiencing more than one inhalation-related reaction will be counted once for this outcome measure.
17 secondary outcomes
Spirometry
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Spirometry
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Spirometry
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Spirometry
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Spirometry
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Oscillometry
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Oscillometry
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Oscillometry
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Plethysmography
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Plethysmography
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Plethysmography
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Six-Minute Walk Test (6MWT)
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
Fractional Exhaled Nitric Oxide (FeNO)
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
St. George's Respiratory Questionnaire (SGRQ)
Time frame: Baseline, Day 28, 3 months, 6 months, 12 months
COPD exacerbations
Time frame: Baseline through 12 months
Computed Tomography (CT)
Time frame: Baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trishul Siddharthan, Medical Doctor principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stem cells in people with Chronic Obstructive Lung Disease, run by SMSbiotech at 1 site in United States.
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 19 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: opening soon, as of the sponsor's last update on 13 Oct 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 United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Chief Clinical Officer (+1, info@smsbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: Baseline through 12 months). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.