Table 1.
The schedule of follow-up of study
| Screening | Follow up | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1st screening | BM hervest | 2nd screening | Pre-administration | Post-administration | |||||||||
| Onset to14 days | Day −7 (±1) | Day 0 | Day 1 | Day 3 | Day 7 | Day 14 | Day 30 (±3) | Day 90 (±30) | Day 180 (±30) | Day 360 (±30) | |||
| Informed consent | X | ||||||||||||
| Medical history | X | ||||||||||||
| Vital signs | X | X | X | X | X | X | X | X | X | X | X | X | X |
| Body weight and height | X | ||||||||||||
| Serological tests | X | X | X | X | X | X | X | X | X | X | X | ||
| Biochemical tests | X | X | X | X | X | X | X | X | X | X | X | ||
| Urinalysis | X | X | X | X | X | X | |||||||
| Urine hCG-β (If needed) | X | X | X | X | X | ||||||||
| Infectious disease inspection | X | ||||||||||||
| 12-lead electrocardiogram | X | X | X | X | X | X | X | ||||||
| Chest X-ray examination | X | X | X | X | X | X | X | ||||||
| Neurological examination | X | X | X | X | X | X | X | X | |||||
| MRI | X | X | X | X | X | X | X | X | X | X | X | ||
| FDG-PET and IMZ-SPECT | X | X | X | X | |||||||||
| Bone marrow harvest | X | ||||||||||||
| Cell product administration | X | ||||||||||||
| Concomitant medication | X | X | X | X | X | X | X | X | X | X | X | X | X |
| Adverse events | X | X | X | X | X | X | X | X | X | X | X | X | X |