A Phase 1, First-in-Human, clinical trial to evaluate the safety of Small Mobile Stem Cells (SMS) delivered into the lung as a potential Organ Regeneration Therapy in Chronic Obstructive Pulmonary Disease (SORT-COPD Study)

SMSbiotech Australia Pty Ltd0 sites18 target enrollmentSeptember 20, 2024

ConditionsChronic Obstructive Pulmonary Disease Respiratory - Chronic obstructive pulmonary disease

Overview

Phase: 未知
Intervention: Not specified
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: SMSbiotech Australia Pty Ltd
Enrollment: 18
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 20, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

SMSbiotech Australia Pty Ltd

Eligibility Criteria

Inclusion Criteria

•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. 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 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.

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 corticosteroids. If currently prescribed Inhaled Corticosteroids, must be willing and able to avoid intake of the morning dose on the days of IP administration, and limit taking the dose until late evening (>12 hours after administration of 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 renal insufficiency, defined as chronic kidney disease stage 2 to stage 5 as per KDIGO 2020 definitions.
•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.
•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.