To investigate the safety and efficacy of autologous adipose-derived mesenchymal stem cell spheroids pretreated with matrillin-3 in chronic low back pain patients with lumbar intervertebral disc degeneration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Adipose-derived mesenchymal stem cells isolated from subject's adipose tissue are pretreated with matrillin 3 and produced in spheroid form.
CHA University, CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
1) Adverse reaction and serious adverse reaction evaluation 2) laboratory inspection 3) Vital signs 4) Biochemical examination 5) Lumbar MRI 6) Monitoring systemic infection
It will be considered safe and tolerated in the absence of the following: * Grade 3 (NCI grading system) or higher adverse reactions related to cell products * Any evidence that the cells are contaminated with infectious substances * Any evidence that cells show tumorigenic potential
Time frame: During Clinical Trial Period
Confirmation of the degree of pain improvement in VAS
on a scale of 0 to 10, with 0 meaning no pain and 10 meaning the worst pain you can imagine
Time frame: before and at 1 week, 1, 3, 6 months after stem cell injection
Confirmation of the degree of improvement in disability (ODI)
on a scale of 0 to 3, with 0 meaning no disability and 10 meaning severe disability
Time frame: before stem cell injection and at 1 week, 1, 3, and 6 months after injection
Confirmation of increase in water content in the nucleus using MRI
Time frame: before stem cell injection and at 1 and 6 month after injection
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