Not yet recruitingPhase 1 / Phase 2

A Study to Investigate Small Mobile Stem Cells (SMS) in Moderate to Severe Chronic Obstructive Pulmonary Disease

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 30 days, 13 months
  • Procedures mentioned: Heart tracing (ECG), Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests SORT-COPD, a treatment made of small mobile stem cells, in 125 adults with moderate to severe COPD, a long-term lung disease. The cells are breathed into the lungs as a mist through a machine called a nebulizer. Researchers will look for changes in breathing health after treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be an adult age 18 or older.
  • Have moderate to severe COPD caused by cigarette smoking or exposure to smoke from burning materials or pollution. Breathing tests will check lung function.
  • Have received COPD treatment before.
  • Have no COPD flare-ups or hospital stays in the 4 weeks before screening, and no COPD medicine changes in the 28 days before screening.
  • Follow study visits and rules, including not smoking during treatment and follow-up.
  • Be willing and able to give written consent to join.
  • Women must not be pregnant or breastfeeding. Those who can become pregnant must have negative pregnancy tests and use accepted birth control through 30 days after the last dose.
  • Men must not donate fresh, unwashed semen during treatment and for at least 30 days after the last dose. They must also use condoms or continue their usual long-term choice not to have sex with women.

Who can't join

  • Have certain other types of COPD, asthma, heart failure, or other listed lung diseases; breathing failure not caused by COPD; or COVID pneumonia with low-oxygen breathing failure in the past 12 weeks.
  • Have long-term kidney problems, uncontrolled high blood pressure, or blood pressure treated with more than two medicines. Some people with mildly low kidney test results may qualify. Heart or blood vessel disease, past stroke or mini-stroke, or diabetes with an HbA1c blood sugar result above 7.5% also rule out joining.
  • Have current or past cancer, or a possible tumor larger than 5 mm on a screening lung scan. Past basal cell or squamous cell skin cancer is allowed.
  • Have HIV, hepatitis B or C, or another condition that weakens the immune system; an infection needing antibiotics that work throughout the body within 12 weeks before screening; or a positive COVID-19, flu, or RSV test on day 1.
  • Use steroid medicines now or within 21 days before screening. Inhaled steroids may be allowed with special timing around study doses. Medicines that weaken the immune system within 14 days before screening or for 3 weeks after the last dose, and experimental treatments within 12 months before joining, are also not allowed.
  • Smoke tobacco or cannabis, or vape, within 28 days before screening. Nicotine patches, gum, and other oral nicotine products are allowed. Alcohol or drug abuse with less than one year of sobriety, or that may affect participation, also rules out joining.
  • Have a body mass index (BMI), a measure based on height and weight, above 60; be pregnant or breastfeeding; or have a severe medicine allergy, including an allergy to cow-derived products.
  • Have another physical or mental health condition that the study doctor thinks could make treatment or finishing the study difficult, or be unable or unwilling to follow study schedules and rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Eligible participants must meet all of the following inclusion criteria: 2. Adult \>18 yrs old (inclusive). 3. 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. • 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). 4. 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. 5. Has previously received treatment for COPD-C or COPD-P. 6. 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. 7. Agrees to comply with study specific procedures and visits, including non-smoking during the treatment and follow-up periods of the study. 8. Willing and able to provide written informed consent. Exclusion Criteria: Participants must not meet any of the exclusion criteria. 1. 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. 2. 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. 3. History of COVID-associated pneumonia with hypoxemic respiratory failure in the 12 weeks prior to screening. 4. 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. 5. 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. 6. Uncontrolled hypertension, or current hypertension controlled on more than two medications. 7. 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). 8. Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c \> 7.5%) at screening. 9. 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. 10. 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. 11. Active infection requiring systemic antibiotic treatment within 12 weeks prior to screening. 12. Body mass index (BMI) \> 60 kg/m2. 13. 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". 14. 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. 15. Pregnant or breastfeeding. 16. Any severe medication allergy, including an allergy to bovine products. 17. 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. 18. Received an experimental therapy (drug or biologic) for any indication within 12 months prior to enrollment. 19. Unable or unwilling to comply with study specific schedules or procedures. 20. Positive test for COVID-19, Influenza A, Influenza B or RSV on day 1.

Study sites (1)

FL

  • University of Miami · Miami, FL 33136Research Project Manager, MPH · Study contact · 305-243-6388Trishul Siddharthan, MD · Principal investigatorMore trials in Miami