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 |