Study Phase | LTx | Â | 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 | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
DLT assessment | X | X | X | X | Â | X | Â | Â | X | Â | Â | Â | Â |
Laboratory | X | X | X | X | X | X | X | X | X | X | X | X | X |
Doppler ultrasound | X | X | X | X | Â | X | Â | Â | X | X | Â | Â | X |
Liver biopsy | X | Â | Â | X | Â | X | Â | Â | Â | Â | Â | Â | Â |
Immunomonitoring | X | Â | X | Â | Â | X | Â | Â | X | Â | Â | Â | X |