Table 6.
Assessment schedule.
| SV | V1 | V2 | V3 | V4 | V5 | V6 | |
|---|---|---|---|---|---|---|---|
| Day | −42 | −21 | 0 | 7 | 30 | 90 | 180 |
| Time window (days) |
NA | ±3 | ±1 | ±1 | ±7 | ±7 | ±7 |
| Informed consent | X | ||||||
| Physical examination | X | X | X | X | X | X | X |
| Vital signs | X | X | X | X | X | X | X |
| Medical history | X | ||||||
| Laboratory assessments | X | X | X | X | X | X | |
| VAS | X | X | X | X | X | X | X |
| ODI | X | X | X | X | X | X | X |
| Lumbar spine X-ray | X | X | X | ||||
| Lumbar spine MRI | X | X | X | ||||
| Liposuction | X | ||||||
| Stem cell transplantation | X | ||||||
| AE assessment | X | X | X | X | |||
| SAE assessment | X | X | X | X |
SV: screen visit; NA: not applicable; V: visit; VAS: visual analogue scale; ODI: Oswestry Disability Index; MRI: magnetic resonance imaging; AE: adverse event; SAE: severe adverse event.