About this trial
The goal of this study is to evaluate the safety and tolerability of TG-C in subjects with chronic discogenic lumbar back pain due to degenerative disc disease. Participants will be administered a single intradiscal injection or subcutaneous injection for sham and followed up with in-clinic visits and telephone calls for 24 months.
Eligibility criteria
Qualifiers
Between the ages of >= 22 and <= 70
Provides written informed consent before undergoing any study specific procedures
Chronic lower back pain for at least 6 months. Back pain twice as great as leg pain measured using NRS
VAS between >= 40 and <= 90
Disqualifiers
Co-morbid medical condition of the spine or upper extremities
Grade 2 or higher spondylolisthesis and type III Modic changes around target disc
Suspicion of full thickness annular tear at disc
History of endocrine or metabolic disorder
Trial design
Treatments tested in this trial
- TG-C High Dose
- TG-C Mid Dose
- TG-C Low Dose
- Sham Control