Study to Determine the Safety and Tolerability of TG-C in Subjects With Back Pain Due to Degenera… (NCT06144970) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Study to Determine the Safety and Tolerability of TG-C in Subjects With Back Pain Due to Degenerative Disc Disease
24 participantsStarted 2027-01-19
Plain-language 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.
Who can participate
Age range
22 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* BMI \>15 and \< 30 kg/m2
* Use birth control
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
* Epidural or facet joint steroid, platelet rich pla…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.