Study to Determine the Safety and Tolerability of TG-C in Subjects With Back Pain Due to Degenerative Disc Disease
- NCT ID
- NCT06144970
- Registry status
- Not yet recruiting
- Study type
- Not specified in the registry data
- Phase
- Phase 1
- Sponsor
- Kolon TissueGene, Inc.
Overview
ClinicalTrials.gov lists this study as Not yet recruiting.
Enrollment: 24 participants (Estimated).
What is being studied
No interventions are listed in the registry data.
Who may be eligible
- Ages
- Not specified in the registry data
- Sex
- Not specified in the registry data
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following 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
* 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
Study locations
No study locations are listed in the registry data.
Study details
- Start date
- January 19, 2027
- Primary completion date
- July 28, 2028
- First posted
- November 22, 2023
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT06144970
- Registry last updated
- August 20, 2026
- QualifiedStudies registry data refreshed
- September 21, 2026
View NCT06144970 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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