Table 2

Study timeline and clinical procedures during the trial

Study procedurePrescreeningScreening phase*Baseline3 months6 months12 months
UC-MSC administration†☑☑
Medication treatment‡☑☑☑☑
Informed consent☑
Inclusion and exclusion criteria☑
Demographic information☑☑
Patients’ medical reports☑☑☑☑☑
Vital signs§/physical examination☑☑☑☑☑
COPD assessment☑☑
COPD GOLD 2019 classification☑☑☑☑☑
Haematology analysis¶☑☑☑☑☑☑
Infectious disease examination/test**☑☑☑
Blood oxygen saturation/arterial blood gas analysis††☑☑☑☑☑☑
Chest CT scan☑☑☑☑
Chest X-ray☑☑☑☑
Pulmonary function analysis☑☑☑☑☑
Adverse event evaluation☑☑☑☑
Mortality/complications monitoring☑☑☑☑

  • *If the results of the screening phase for UC-MSC groups are within 30 days of UC-MSC administration, they will be automatically considered as the baseline level.

  • †Applies only for the UC-MSC group at baseline and 3 months.

  • ‡Treatment medication applies for all testing groups based on patients’ COPD classification according to GOLD 2019 guidelines.

  • §Vital signs include body temperature, blood pressure, heart rate, respiratory rate, oxygen saturation and patient body weight.

  • ¶Haematological analysis included white cell count, platelet count, red cell count, haemoglobin, percentage of lymphocytes, neutrophils, monocytes, eosinophils, basophils, C reactive protein, pro-BNP and troponin-T and D-dimer.

  • **Infectious diseases include hepatitis, syphilis, HIV, HBV and tuberculosis.

  • ††Blood gas analysis includes pH, PaO2, PaCO2, BE, HCO3-.

  • COPD, chronic obstructive pulmonary disease; GOLD, Global Initiative for Chronic Obstructive Lung Disease; HBV, hepatitis B virus; UC-MSC, umbilical cord-derived mesenchymal stem/stromal cells.