A Phase I, Double-blind, Randomized, Sham-controlled, Dose-response, Study Evaluating the Safety and Tolerability of TG-C in Subjects with Chronic Discogenic Lumbar Back Pain Due to Degenerative Disc Disease At 6 and 12 Months
Overview
- Phase
- Phase 1
- Intervention
- TG-C Low Dose
- Conditions
- Degenerative Disc Disease
- Sponsor
- Kolon TissueGene, Inc.
- Enrollment
- 24
- Primary Endpoint
- Treatment-emergent adverse events
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
A Phase I, Double-blind, Randomized, Sham-controlled, Dose-response, Study Evaluating the Safety and Tolerability of TG-C in Subjects with Chronic Discogenic Lumbar Back Pain due to Degenerative Disc Disease at 6 and 12 Months, male or female subjects with chronic discogenic lumbar back pain due to degenerative disc disease at one level. TG-C is to be administered by a single intradiscal injection to the damaged disc via fluoroscopic guidance. Sham will be a normal saline subcutaneous injection. Subjects will be followed for 24 months with in-clinic visits and telephone calls after study drug administration.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •ODI Index \>30 and \<= 80
- •Inadequate response to at least one medication (e.g., NSAID, acetaminophen, muscle relaxant) and some form of formal physical therapy over a period of at least 6 months, within 6-9 months of screening.
- •Diagnosis of DDD from L1 to S1, confirmed by patient history and radiographic studies
- •Modified Pfirrmann score of 3-7 on MRI
- •With or without contained disc herniations of \<3 mm protrusion
- •If more than 1 degenerative disc is identified. PD must be performed 30 days prior and ensure only one level is the pain generator
Exclusion Criteria
- •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
- •Rheumatoid or psoriatic arthritis
- •Compressive pathology due to stenosis or herniated or sequestered discs
- •Symptomatic involvement of more than one lumber disc
- •Intact disc bulge/protrusion at \>3 mm
- •Lumbar intervertebral foraminal stenosis
- •Previous surgery at the target disc level
Arms & Interventions
Active Treatment 1
Low dose TG-C 1.5 x 10e6 cells
Intervention: TG-C Low Dose
Active Treatment 2
Middle dose TG-C 5.0 x 10e6 cells
Intervention: TG-C Mid Dose
Active Treatment 3
High dose TG-C 1.5 x 10e7 cells
Intervention: TG-C High Dose
Sham Control
single subcutaneous injection of normal saline
Intervention: Sham Control
Outcomes
Primary Outcomes
Treatment-emergent adverse events
Time Frame: 6 and 12 months
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
Secondary Outcomes
- Compare pain severity using a Visual Analogue Scale(6 and 12 months)
- Oswestry Disability Index survey(6 and 12 months)