Consultation visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 111 | 12 | 13 | 14 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Days | (−10) to (−3) | 1 | 3 or 4 | 5 | 6 | 7 | 8 | 11 | 16±2 | 22±2 | 29±3 | 168±14 | 252±14 | 336±14 |
Parameter | Screening2 | MSC infusion3 | Tumor resection | GCV infusions4 | ||||||||||
Informed consent | X | |||||||||||||
Inclusion/exclusion criteria | X | |||||||||||||
Medical history/demography | X | |||||||||||||
Physical examination | X | X | ||||||||||||
Adverse events | X | X | X | X | X | X | X | X | X | X | ||||
Concomitant medication | X | X | X | X | X | X | X | X | X | X | X | |||
Vital signs | X | X5 | X6 | X7 | X7 | X | X | X | ||||||
Body weight | X | X8 | X9 | X | X | X | ||||||||
12-lead ECG | X | X | X | |||||||||||
Cardiac monitoring | X10 | X11 | X12 | |||||||||||
Oxygen saturation | X13 | X11 | X12 | X | ||||||||||
Tumor marker 14 | X | X | X | |||||||||||
Tumor status | X | X | ||||||||||||
MSC_apceth infusion | X | |||||||||||||
Tumor resection 15 | X | |||||||||||||
GCV infusion | X | X | X | |||||||||||
Serum pregnancy test | X | X | ||||||||||||
Urine analysis | X | X | X | |||||||||||
Hematology | X | X | X | X | X | X | ||||||||
Blood chemistry | X | X | X | X | X | X | ||||||||
Creatinine clearance | X | |||||||||||||
Inflammation markers | X | X | X | |||||||||||
Coagulation markers | X | X | X9 | X | X | X | ||||||||
Infectious disease markers | X | X | ||||||||||||
Lymphocyte subsets | X | X | ||||||||||||
Biomarker samples | X | X | ||||||||||||
Retention samples | X8 | X | X | X | ||||||||||
Immunogenicity samples | X | X | ||||||||||||
ECOG | X | X | ||||||||||||
Disease status | X | X | X |