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

Not yet recruitingPhase 1NCT06144970
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
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
Interventions
  • Biological: TG-C High Dose
  • Biological: TG-C Mid Dose
  • Biological: TG-C Low Dose
  • Biological: Sham Control
Sponsor
Kolon TissueGene, Inc.
Start date
2027-01-19
Primary completion
2028-07-28
Sex
All
Age range
from 22 Years to 70 Years
Results posted
No results posted in this snapshot
Total sites listed
0

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06144970