A Phase 1/2 interventional study of administered an autologous adipose-derived mesenchymal stem cell spheroid pretreated with matrillin 3 in Patients With Chronic Low Back Pain Due to Degenerative Lumbar Disc, sponsored by Inbo Han. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-08-25.
Sponsored by Inbo Han · Phase 1/2, Interventional, and Treatment
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.
464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.
This study's planned enrollment of 4 is below the median of 60 across 261 interventional studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →Inbo Han is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Among female patients who are likely to become pregnant during the clinical trial, who do not use medically acceptable methods of contraception
Adipose-derived mesenchymal stem cells isolated from subject's adipose tissue are pretreated with matrillin 3 and produced in spheroid form.
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
Plan to share: Undecided
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration→
Inbo Han