The objective of this study is to assess the safety and tolerability of YH14618 during 24 weeks of follow-up period after single administration in patients with degenerative disc disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
48
Kangbuk Samsung Medical Center
Seoul, South Korea
Evaulate the safety and tolerability after single intradiscal administation
Safety outcomes * Adverse events * 12-lead EKG * Physical examination * Standard lab results(hematology, blood chemistry, coagulation, urinalysis etc.)
Time frame: 12 weeks of observational period
Change from baseline in disc height index at 12 week
Time frame: Baseline, Week 12
Change from baseline in magnetic resonance imaging(MRI) index
Time frame: Baseline, Week 12
Change from oswestry diability index(ODI) at week 12
Time frame: Baseline, Week 12
Change from baseline in visual analogue scale(VAS) at week 12
Time frame: Baseline, Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
0mg/disc