Table 2.

Study timeline and clinical procedures during the trial

Study procedure	Prescreening	Screening phase*	Baseline	3 months	6 months	12 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.