[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659873":3},{"organization":4,"outcomesModule":7,"designInfo":109,"detailedDescription":115,"studyPopulation":108,"armGroups":116,"interventions":127,"overallOfficials":135,"centralContacts":140,"locations":146,"responsibleParty":165,"collaborators":108,"id":167,"slug":168,"hasResults":169,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":169,"sex":175,"minAge":176,"maxAge":108,"enrollmentInfo":177,"targetDuration":108,"studyType":180,"phases":181,"briefSummary":184,"conditions":185,"keywords":108,"overallStatus":187,"whyStopped":108,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},{"fullName":5,"class":6},"SMSbiotech","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":63,"otherOutcomes":108},[9,13,17,21,24,27,30,33,36,39,42,45,48,51,54,57,60],{"measure":10,"description":11,"timeFrame":12},"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)","Baseline through 12 months",{"measure":14,"description":15,"timeFrame":16},"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","Baseline through Day 28",{"measure":18,"description":19,"timeFrame":20},"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.","Baseline, Day 28, 3 months, 6 months, 12 months",{"measure":22,"description":23,"timeFrame":20},"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.",{"measure":25,"description":26,"timeFrame":20},"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.",{"measure":28,"description":29,"timeFrame":20},"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.",{"measure":31,"description":32,"timeFrame":20},"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.",{"measure":34,"description":35,"timeFrame":20},"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.",{"measure":37,"description":38,"timeFrame":20},"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.",{"measure":40,"description":41,"timeFrame":20},"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.",{"measure":43,"description":44,"timeFrame":20},"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.",{"measure":46,"description":47,"timeFrame":20},"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.",{"measure":49,"description":50,"timeFrame":20},"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.",{"measure":52,"description":53,"timeFrame":20},"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.",{"measure":55,"description":56,"timeFrame":20},"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.",{"measure":58,"description":59,"timeFrame":20},"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.",{"measure":61,"description":62,"timeFrame":20},"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.",[64,67,69,71,73,75,78,80,82,85,87,89,92,95,98,101,104],{"measure":65,"description":66,"timeFrame":20},"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\u002FERS standards",{"measure":65,"description":68,"timeFrame":20},"Within-participant change from baseline in post-bronchodilator FEV1 z-score, calculated using GLI Global reference equations",{"measure":65,"description":70,"timeFrame":20},"Within-participant change from baseline in Percent Predicted FEV1 (ppFEV1), measured in percentage points and calculated using GLI Global reference equations",{"measure":65,"description":72,"timeFrame":20},"Within-participant change from baseline in Forced Vital Capacity (FVC), measured in liters (L), performed according to ATS\u002FERS standards",{"measure":65,"description":74,"timeFrame":20},"Within-participant change from baseline in FEV1\u002FFVC Ratio, measured as a percentage (%)",{"measure":76,"description":77,"timeFrame":20},"Oscillometry","Within-participant change from baseline in respiratory system Resistance (Rrs) over differing frequencies, measured in cmH2O\u002FL\u002Fs, performed according to ERS technical standards",{"measure":76,"description":79,"timeFrame":20},"Within-participant change from baseline in respiratory system Reactance (Xrs) over differing frequencies, measured in cmH2O\u002FL\u002Fs, performed according to ERS technical standards",{"measure":76,"description":81,"timeFrame":20},"Within-participant change from baseline in Reactance Area (AX), measured in cmH20\u002FL",{"measure":83,"description":84,"timeFrame":20},"Plethysmography","Within-participant change from baseline in Functional Residual Capacity (FRC), measured in liters (L), performed according to ATS\u002FERS standards",{"measure":83,"description":86,"timeFrame":20},"Within-participant change from baseline in Total Lung Capacity (TLC), measured in liters (L), performed according to ATS\u002FERS standards",{"measure":83,"description":88,"timeFrame":20},"Within-participant change from baseline in Ratio of Residual Volume (RV\u002FTLC), measured as a percentage (%)",{"measure":90,"description":91,"timeFrame":20},"Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)","Within-participant change from baseline in DLCO",{"measure":93,"description":94,"timeFrame":20},"Six-Minute Walk Test (6MWT)","Within-participant change from baseline in 6MWT total distance, heart rate, oxygen saturation, fatigue score, and dyspnea score",{"measure":96,"description":97,"timeFrame":20},"Fractional Exhaled Nitric Oxide (FeNO)","Within-participant change from baseline in FeNO",{"measure":99,"description":100,"timeFrame":20},"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.",{"measure":102,"description":103,"timeFrame":12},"COPD exacerbations","Number of exacerbations, time to first exacerbation, exacerbations requiring systemic corticosteroids or antibiotics, emergency department visits, and hospitalizations",{"measure":105,"description":106,"timeFrame":107},"Computed Tomography (CT)","CT lung densitometry","Baseline and 12 months",null,{"allocation":110,"interventionModel":111,"interventionModelDescription":108,"primaryPurpose":112,"observationalModel":108,"timePerspective":108,"maskingInfo":113},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":114,"maskingDescription":108,"whoMasked":108},"NONE","SORT-COPD II is a Phase 1b\u002F2a, 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.\n\nSMS 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.\n\nUp 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.\n\nIf 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.\n\nAll 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.\n\nFor 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.\n\nParticipants 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.",[117,123],{"label":118,"type":119,"description":120,"interventionNames":121},"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.",[122],"Biological: Stem cells",{"label":124,"type":119,"description":125,"interventionNames":126},"Expansion Cohort (Phase 2a)","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.",[122],[128],{"type":129,"name":130,"description":131,"armGroupLabels":132,"otherNames":133},"BIOLOGICAL","Stem 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\u002F2a study designed to evaluate the safety, tolerability, and potential effects of SMS cells in people with moderate to severe COPD.",[124,118],[134],"Small Molecule Stem (SMS) Cells",[136],{"name":137,"affiliation":138,"role":139},"Trishul Siddharthan, Medical Doctor","University of Miami","PRINCIPAL_INVESTIGATOR",[141],{"name":142,"role":143,"phone":144,"phoneExt":108,"email":145},"Chief Clinical Officer","CONTACT","+1","info@smsbiotech.com",[147],{"facility":138,"status":108,"city":148,"state":149,"zip":150,"country":151,"countryCode":152,"cosmosGeoPoint":153,"geoPoint":158,"contacts":159},"Miami","Florida","33136","United States","US",{"type":154,"coordinates":155},"Point",[156,157],-80.19366,25.77427,{"lat":157,"lon":156},[160,163],{"name":161,"role":143,"phone":162,"phoneExt":108,"email":108},"Research Project Manager, MPH","305-243-6388",{"name":164,"role":139,"phone":108,"phoneExt":108,"email":108},"Trishul Siddharthan, MD",{"type":166,"investigatorFullName":108,"investigatorTitle":108,"investigatorAffiliation":108,"oldNameTitle":108,"oldOrganization":108},"SPONSOR","100659873","phase-1-a-study-to-investigate-small-mobile-stem-cells-sms-in-moderate-to-severe-chronic-obstructive-pulmonary-disease-100659873",false,"NCT07871890","A Study to Investigate Small Mobile Stem Cells (SMS) in Moderate to Severe Chronic Obstructive Pulmonary Disease","A Phase 1b\u002F2a, 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)","SORT-COPD II","Inclusion Criteria:\n\n1. Eligible participants must meet all of the following inclusion criteria:\n2. Adult \\>18 yrs old (inclusive).\n3. Female participants:\n\n   * A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:\n\n     * Is a woman of nonchildbearing potential (WONCBP) OR\n     * 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.\n   * 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.\n\n   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.\n\n   • 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.\n\n   Male participants:\n\n   • 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:\n   * Refrain from donating fresh unwashed semen.\n   * 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\u002Fbarrier (male condom).\n4. 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\\].\n\n   Lung impairment will be determined with post-bronchodilator FEV1 spirometry.\n5. Has previously received treatment for COPD-C or COPD-P.\n6. 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.\n7. Agrees to comply with study specific procedures and visits, including non-smoking during the treatment and follow-up periods of the study.\n8. Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\nParticipants must not meet any of the exclusion criteria.\n\n1. 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.\n2. 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.\n3. History of COVID-associated pneumonia with hypoxemic respiratory failure in the 12 weeks prior to screening.\n4. 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.\n5. History of chronic renal insufficiency, defined as an eGFR \\\u003C 90 mL\u002Fmin\u002F1.73 m² \\[3\\] and\u002For 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\u002Fmin\u002F1.73 m², may be enrolled and receive IP per the investigator's discretion.\n6. Uncontrolled hypertension, or current hypertension controlled on more than two medications.\n7. 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).\n8. Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c \\> 7.5%) at screening.\n9. History or active malignancy, including any potential neoplasm detected via high-resolution CT scan (nodule \\> 5 mm) detected as part of the screening process.\n\n   People with a history of basal cell or squamous cell carcinoma of the skin are eligible.\n10. 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.\n11. Active infection requiring systemic antibiotic treatment within 12 weeks prior to screening.\n12. Body mass index (BMI) \\> 60 kg\u002Fm2.\n13. 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\".\n14. 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.\n15. Pregnant or breastfeeding.\n16. Any severe medication allergy, including an allergy to bovine products.\n17. 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.\n18. Received an experimental therapy (drug or biologic) for any indication within 12 months prior to enrollment.\n19. Unable or unwilling to comply with study specific schedules or procedures.\n20. Positive test for COVID-19, Influenza A, Influenza B or RSV on day 1.","ALL","18 Years",{"count":178,"type":179},125,"ESTIMATED","INTERVENTIONAL",[182,183],"PHASE1","PHASE2","This study is a phase 1b\u002F2a, open-label, non-randomized, observation of 125 adults, with moderate to severe chronic obstructive pulmonary disease, treated with SORT-COPD (SMS cells).\n\nThe 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.",[186],"Chronic Obstructive Lung Disease","NOT_YET_RECRUITING","2026-10-06",{"date":190,"type":191},"2026-10-13","ACTUAL",{"date":193,"type":179},"2026-10-01",{"date":195,"type":179},"2027-12",{"name":5,"class":6},1]