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Table 1 Assessment schedule

From: Safety and tolerability of intradiscal implantation of combined autologous adipose-derived mesenchymal stem cells and hyaluronic acid in patients with chronic discogenic low back pain: 1-year follow-up of a phase I study

  SV V1 V2 V3 V4 V5 V6 V7 V8 V9
Day –35 –21 0 1 7 30 90 180 270 360
Time window (days) NA ±3 ±1 ±1 ±3 ±7 ±7 ±7 ±7 ±7
Informed consent ×          
Physical examination × × × × × × × × × ×
Vital signs × × × × × × × × × ×
Medical history ×          
Laboratory assessments ×   × × × × × × × ×
VAS × × × × × × × × × ×
ODI × × × × × × × × × ×
SF-36 × × × × × × × × × ×
Lumbar spine X-ray imaging ×      ×   ×   ×
Lumbar spine MRI ×      ×   ×   ×
BMD measurement ×          
Electromyography ×          
Discography ×          
Liposuction   ×         
Stem cell transplantation    ×        
AE assessment      × × × × × ×
SAE assessment      × × × × × ×
  1. SV screen visit, NA not applicable, V visit, VAS visual analogue scale, ODI Oswestry Disability Index, SF-36 Short Form-36, MRI magnetic resonance imaging, BMD bone mineral density, AE adverse events, SAE severe adverse event