Status:
NOT_YET_RECRUITING
Study to Determine the Safety and Tolerability of TG-C in Subjects with Back Pain Due to Degenerative Disc Disease
Lead Sponsor:
Kolon TissueGene, Inc.
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
22-70 years
Phase:
PHASE1
Brief 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 sin...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06144970
Start Date
November 1 2025
End Date
November 1 2027
Last Update
December 11 2024
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