|
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
|
- Footnotes:1 in case subsequent chemo- or radiotherapy begins before day 29 all investigations of this day are to be carried out up to 5 days before therapy starts. Thereafter, no further AE recording is required; 2 not earlier than 2 weeks after end of chemo-/radiotherapy; 3 24 h (±2 h) inpatient monitoring after end of MSC infusion; 4 24 h (±3 h) inpatient monitoring after start of 1st GCV infusion and including the 3rd GCV infusion; 5 Before and 15, 30, 60 min, 2 h, 4 h (±0.5 h), 6 h (±1 h), 8 h (±1 h), 12 h (±3 h), and 24 h (±2 h) after the end of MSC_apceth_101 infusion; 6 Before and 15, 30, 60 min, 2 h, 4 h (±0.5 h), 6 h (±1 h), 8 h (±1 h), 12 h after start of 1st GCV infusion and before and 15, 30, 60 min and 2 h after 2nd GCV infusion; 7 Before and 15, 30, 60 min, 2 h after the start of each GCV infusion; 8 before MSC infusion; 9 before 1st GCV infusion; 10 Before and 6 h (±1 h) and 24 h (±2 h) after end of MSC infusion; 11 Before and 6 h (±1 h) after start of 1st GCV infusion; 12 1.5 h (±0.5 h) after start of 3rd GCV infusion; 13 Before and 6 h (±1 h) and 24 h (±2 h) after end of insufion of MSCs; 14 tumor marker: CEA, CA15-3, CA19-9, CA125, CA72-4, Cyfra21-1, AFP; only tumor marker applying for the tumor entity are determined; 15 Including biopsy of surrounding healthy tissue (will be used to detect MSCs) and should be at least 48 h after MSC infusion.
