Treatment of Chronic Obstructive Pulmonary Disease by Infusion of Allogenic Mesenchymal Stem Cells
Trial Parameters
Brief Summary
This phase II study is a randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of UMC119-06-05 compared to placebo in treating subjects with moderate to severe COPD. Eligible subjects will receive a single-dose IV infusion of UMC119-06-05 or placebo.
Eligibility Criteria
Inclusion Criteria: 1. Between ≥40 and ≤80 years of age, of either sex and of any race. 2. With diagnosis of COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) standard. 3. Has a post-bronchodilator FEV1/FVC ratio \<0.70. 4. Has a post-bronchodilator FEV1 predicted value ≥30% and \<80%. 5. With a score ≥2 in the mMRC dyspnea scale. 6. With a score ≥10 in the COPD Assessment Test (CAT). 7. With a body weight ≥40 to ≤90 kg. 8. The disease status of COPD has been stable as determined by the investigator, and the standard treatment for COPD was not adjusted within 3 months prior to screening. 9. Is a current or ex-smoker, with a cigarette smoking history of ≥10 years or \>10 pack-years. 10. Women of child-bearing potential should have a negative urine pregnancy test at screening, UNLESS they meet the following criteria: (1)Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with the serum follicle stimulating hor