Phase
Condition
Emphysema
Chronic Obstructive Pulmonary Disease (Copd)
Copd (Chronic Obstructive Pulmonary Disease)
Treatment
Stem cells
Clinical Study ID
Ages 39-69 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged 39 to 69 years (inclusive).
Female participants: A female participant is eligible to participate if she is not pregnant orbreastfeeding, and one of the following conditions applies: Is a woman of nonchildbearing potential (WONCBP) OR Is a woman of childbearingpotential (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 asrequired by local regulations) at Screening and on Day 1, prior to administration ofstudy intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serumpregnancy test is required. In such cases, the participant must be excluded fromparticipation 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 anearly undetected pregnancy.
Male participants: Male participants are eligible to participate if they agree to the following duringthe study intervention period and for at least 30 days after the last dose of studyintervention: Refrain from donating fresh unwashed semen. Be abstinent from heterosexualintercourse as their preferred and usual lifestyle (abstinent on a long-term andpersistent basis) and agree to remain abstinent OR must agree to usecontraception/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 forChronic 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 toscreening, no hospitalizations in the 12 weeks prior to screening, and no changes inCOPD medication in the 28 days prior to screening.
Agrees to comply with study specific procedures and visits, including non-smokingduring the treatment and follow-up periods of the study.
Willing and able to provide written informed consent.
Exclusion
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 bronchiolitisor 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'slung disease), or detection of any of these conditions through screening CTscanning.
History of COVID associated pneumonia with hypoxemic respiratory failure in the 12weeks prior to screening.
Current use, or use within 21 days of screening, of systemic corticosteroids.Participants on inhaled corticosteroids or combined inhaled therapies can beincluded, 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 2.5times the upper limit of normal (ULN) Total bilirubin more than two times the ULNParticipants 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 havean eGFR detected between 60-89 mL/min/1.73 m2, should have their eGFR repeated asper standard clinical procedure.
Uncontrolled hypertension, or current hypertension controlled on more than twomedications.
History, within the last two years, of coronary artery disease, coronary arterybypass graft surgery, percutaneous transluminal coronary angioplasty, severeperipheral arterial disease, cerebrovascular disease (including history of transientischemic attack or cerebrovascular accident), or any such history that, in theopinion of the investigator, will impact participation in the study.
Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c > 7.5%) atscreening.
No active malignancy in the last three years, including any potential neoplasmdetected via high-resolution CT scan (nodule > 5 mm) detected as part of thescreening process. People with a history of basal cell or squamous cell carcinoma of the skin areeligible.
History of HIV or other immunosuppressed conditions, Hepatitis B or Hepatitis C, oruse of immunosuppressive medications within 14 days prior to screening, and for 3weeks after the last dose of study intervention is administered.
Active infection requiring systemic antibiotic treatment within 12 weeks prior toscreening.
Body mass index (BMI) > 60 kg/m2.
Active smoking of tobacco, cannabis or vaping in the 28 days prior to screening asindicated by results of cotinine urine testing, performed at screening. Use ofnicotine containing products such as nicotine patches, oral nicotine products ornicotine chewing gum is permitted, noting that cotinine results will be positive.Positive results will be documented by the investigator as "attributed to permittednicotine products".
History of alcohol or other substance abuse, with sobriety less than one year, orthat 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 thePrincipal Investigator might render the subject unlikely to tolerate the inhalationof SORT-COPD (SMS cells), or to complete the study.
Current participation in any other clinical trial or participation in the last sixweeks or subject received an experimental therapy (drug or biologic) for anyindication within 12 months prior to enrolment.
Unable or unwilling to comply with study specific schedules or procedures.
Study Design
Study Description
Connect with a study center
Veritas Research
Bayswater, Victoria 3153
AustraliaActive - Recruiting
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