Stem Cell Research & Therapy

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					×	×	×	×	×	×

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

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ISSN: 1757-6512

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