Study to Determine the Safety and Tolerability of TG-C in Subjects With Back Pain Due to Degenerative Disc Disease

Starting soon · Phase 1 · Has a placebo group

Conditions studied: Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT06144970

Run by

Kolon TissueGene, Inc.

People needed

24

Starts

2027-01-19

Expected to finish

2029-07-28

Last updated by the study team

2026-05-27

Who can join

Age: 22 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 plasma (PRP) or bone marrow concentrate (BMC) injections, or radio frequency ablation (RFA), within 6 months prior to baseline.
• Pregnant
• Presence of ferromagnetic implants
• Involved in current or pending spinal litigations
• Care is provided under a Worker's Compensation claim
• Physical or mental conditions
• 3 or more of the 5 Waddell signs
• Positive screen for HIV
• Immediate family member of other participating patients
• Participated within 3 months or is concurrently enrolled in non-interventional research
• Transient or has a history of any substance use disorder
• Currently incarcerated
• Investigator site personnel or immediate family or sponsor employee
• On chronic anti-coagulation therapy or have confirmed coagulopathy
• Tested positive on RCR testing at screening

Full record on ClinicalTrials.gov

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