NCT06491043
Treatment of Chronic Obstructive Pulmonary Disease by Infusion of Allogenic Mesenchymal Stem Cells
Track this trial
Free. We email you which fields changed when ClinicalTrials.gov updates this record.
Record History
All 1 version: 1 with changes below.
- Study First Submitted
Endpoints
Primary
Incidence of treatment-emergent adverse events (TEAEs)
Timeframe: From Baseline to Day 90]
Incidence of related TEAEs and serious adverse events (SAEs)
Timeframe: through the study
Incidence of withdrawals due to adverse events (AEs)
Timeframe: through the study
Change/shift from baseline in laboratory tests
Timeframe: Baseline, 2 hours (h), Days 3, 7, 14, 28, 90
Change from baseline in vital signs
Timeframe: Baseline, 0 minute, 2 h, Days 3, 7, 14, 28, 90
shift from baseline in ECG results
Timeframe: Baseline, 2 h, Day 14
Shift from baseline in physical examination results
Timeframe: Baseline, 2 h, Days 3, 7, and 14
Secondary (10)
Mean change from baseline in forced vital capacity (FVC)
Mean change from baseline in forced expiratory volume in one second (FEV1)
Mean change from baseline in FEV1/FVC ratio
Mean change from baseline in 6-minute walk test
Mean change from baseline in St. George's Respiratory Questionnaire (SGRQ) score
Show 5 moreShow less
Shift from baseline in modified Medical Research Council (mMRC) dyspnea scale
Incidence, frequency, and severity of COPD exacerbations
Time to first COPD exacerbation
9. Mean change or shift from baseline in Body mass index, airflow Obstruction, Dyspnea, and Exercise capacity (BODE) index
he number of times that rescue medication is used
Arms and interventions
placeboPlacebo comparator
normal saline, 4% human serum albumin
low-dose UMC119-06-05 treatmentExperimental
normal saline, 4% human serum albumin, 1×10\^8 cells/subject
high-dose UMC119-06-05 treatmentExperimental
normal saline, 4% human serum albumin, 2×10\^8 cells/subject
Other: UMC119-06-05
Sites
2 sites in 1 country