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.
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
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
Parallel
TG-C High Dose
Biological/VaccineHigh Dose - 1 mL of the combined TG-C cells
TG-C Mid Dose
Biological/VaccineMiddle Dose - A volume of 2 mL CS10 and 1 mL combined TG-C cells. 1.0 mL volume of the mixed TG-C cells is injected
TG-C Low Dose
Biological/VaccineLow Dose - A volume of 9 mL CS10 and 1 mL combined TG-C cells. 1.0 mL volume of the mixed TG-C cells is injected
Sham Control
Biological/VaccineSingle subcutaneous injection of normal saline
Treatment-emergent adverse events
The safety and tolerability of the TG-C injection for the treatment of degenerative disc disease resulting in chronic discogenic lumbar back pain will be evaluated by summarizing adverse events by treatment
Compare pain severity using a Visual Analogue Scale
Assessment of change from baseline in target back pain using the Visual Analog Scale (VAS). The VAS is a method for the assessment of the intensity of pain. The VAS is a horizontal line, 100 mm in length and anchored by word descriptors at each end (no pain, very severe pain). The patient marks on the line at the point that represents their current state. The VAS score is determined by measuring in millimeters from the left hand end to the point of the mark. The score ranges from "0" or no pain to "100" very severe pain.
Oswestry Disability Index survey
Survey results compared to patient baseline
Treatment-emergent adverse events
The safety and tolerability of the TG-C injection for the treatment of degenerative disc disease resulting in chronic discogenic lumbar back pain will be evaluated by summarizing adverse events by treatment
Compare pain severity using a Visual Analogue Scale
Assessment of change from baseline in target back pain using the Visual Analog Scale (VAS). The VAS is a method for the assessment of the intensity of pain. The VAS is a horizontal line, 100 mm in length and anchored by word descriptors at each end (no pain, very severe pain). The patient marks on the line at the point that represents their current state. The VAS score is determined by measuring in millimeters from the left hand end to the point of the mark. The score ranges from "0" or no pain to "100" very severe pain.
Oswestry Disability Index survey
Survey results compared to patient baseline
Numerical Rating Scale
Compare severity of lower back pain to patient baseline using a Numerical Rating Scale (NRS). Patients rate their pain at baseline and 6 and 12 months after treatment. Patients will use an eleven point numerical scale to record their pain severity with 0 being no pain and 10 being worst possible pain.
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