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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