Table 1.
Study Phase | LTx | EOT | Post-Treatment Phase | Follow-Up | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Visit no. | 1 | 2 | 3 | 4 | 5-9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 |
Study days | 1 | 2 | 3 | 4 | 5-9 | 10 | 14 | 20 | 30 ± 10 d |
90 ± 30 d |
180 ± 30 d |
270 ± 30 d |
365 ± 30 d |
MAPC treatment | X | X | |||||||||||
DLT assessment | X | X | X | X | X | X | |||||||
Laboratory | X | X | X | X | X | X | X | X | X | X | X | X | X |
Doppler ultrasound | X | X | X | X | X | X | X | X | |||||
Liver biopsy | X | X | X | ||||||||||
Immunomonitoring | X | X | X | X | X |